AzTrials
AzTrials

In Vitro FertilizationPhase 3TrustNCT00696878

Corifollitropin Alfa in Participants Undergoing Repeated Controlled Ovarian Stimulation (COS) Cycles Using a Multiple Dose Gonadatropin Releasing Hormone (GnRH) Antagonist Protocol (Study 38825)(P05714)

A Phase 3 study testing Corifollitropin alfa, FSH and GnRH antagonist in people with In Vitro Fertilization, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of the trial is to assess the non-immunogenicity and safety of corifollitropin alfa (also known as Org 36286, SCH 900962 and MK-8962) in participants undergoing repeated COS cycles using a multiple dose GnRH antagonist protocol. Read more about this study

Who is it for?
Ages 18 to 39 years, women only
Conditions the study is for
In Vitro Fertilization
What is being tested?
Corifollitropin alfa, FSH and GnRH antagonist
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
682 participants
Where
No sites listed yet
Study dates
26 Sep 2006to 15 May 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 39 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Females of couples with an indication for COS and IVF or ICSI;
  • >=18 and <=39 years of age at the time of signing informed consent;
  • Body weight > 60 kg and body mass index (BMI) >=18 and <=29 kg/m^2;
  • Normal menstrual cycle length: 24-35 days;
  • Availability of ejaculatory sperm (use of donated and/or cryopreserved sperm is allowed);
  • Willing and able to sign informed consent.

Who cannot join

  • History of or any current (treated) endocrine abnormality;
  • History of ovarian hyper-response or history of ovarian hyperstimulation syndrome (OHSS);
  • History of or current polycystic ovary syndrome (PCOS);
  • More than 20 basal antral follicles (size: <11 mm, both ovaries combined) as measured on USS in the early follicular phase (menstrual cycle day 2-5);
  • Less than 2 ovaries or any other ovarian abnormality, including endometrioma >10 mm (visible on USS);
  • Presence of unilateral or bilateral hydrosalpinx (visible on USS);
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  • More than three unsuccessful COS cycles since the last established ongoing pregnancy (if applicable);
  • History of non- or low ovarian response to FSH/human menopausal gonadotrophin (hMG) treatment;
  • FSH > 12 IU/L or luteinizing hormone (LH) > 12 IU/L as measured by the local laboratory (sample taken during the early follicular phase: menstrual cycle day 2-5);
  • Any clinically relevant abnormal laboratory value based on a sample taken during the screening phase, including abnormal cervical smear (Papanicolaou [PAP]>=III, cervical intraepithelial neoplasia [CIN]>=1);
  • Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts) or GnRH antagonists (e.g. hypersensitivity, pregnancy/lactation);
  • Recent history of or current epilepsy, human immunodeficiency virus (HIV) infection, thrombophilia, diabetes or cardiovascular, gastro-intestinal, hepatic, renal, or pulmonary disease;
  • Abnormal karyotyping of the participant or her partner (if karyotyping is performed);
  • History or presence of alcohol or drug abuse within 12 months prior to signing informed consent;
  • Previous use of corifollitropin alfa;
  • Use of hormonal preparations within 1 month prior to screening;
  • Administration of investigational drugs within three months prior to signing informed consent.

About this study

Official title: A Phase III, Uncontrolled Trial to Assess the Non-immunogenicity and Safety of Org 36286 in Patients Undergoing Repeated Controlled Ovarian Stimulation Cycles Using a Multiple Dose GnRH Antagonist Protocol

The objective of the trial is to assess the non-immunogenicity and safety of corifollitropin alfa (also known as Org 36286, SCH 900962 and MK-8962) in participants undergoing repeated COS cycles using a multiple dose GnRH antagonist protocol.

Read the detailed description

This trial is designed as an open-label, uncontrolled, repeated cycle trial to assess the non-immunogenicity and safety of corifollitropin alfa in participants undergoing repeated COS cycles for in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) using a multiple dose GnRH antagonist protocol. The trial period per participant will cover 1, 2 or 3 COS treatment cycles and no more than three (in-between two stimulation cycles) Frozen-Thawed Embryo Transfer (FTET) cycles following either or both of the first two treatment cycles. In each stimulation cycle, participants receive a single injection of corifollitropin alfa and one week later, treatment is continued with a daily dose of any FSH-containing preparation up to the day of (rec)hCG administration for final oocyte maturation. Assessment of anti-corifollitropin alfa antibodies and local tolerance after corifollitropin alfa injection are important safety endpoints in this trial.

Being tested
Corifollitropin alfa, FSH, GnRH antagonist, (rec)hCG, Progesterone
Keywords
Infertility, Pharmacological effects of drugs, Hormones, Hormone Substitutes and Hormone Antagonists, Pharmacological Actions, Multi-center
Medical subject headings
Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Corifollitropin alfaDrug

    Also called Org 36286, SCH 900962, MK-8962

    Corifollitropin alfa 150 µg administered as a single subcutaneous dose.

  • FSHBiological

    FSH administerd subcutaneously at a dose not to exceed 225 IU/day.

  • GnRH antagonistBiological

    GnRH antagonist administered subcutaneously at a dose of 0.25 mg/day.

  • (rec)hCGBiological

    (rec)hCG administered subcutaneously at a dose of 5,000-10,000 IU/250 µg.

  • ProgesteroneDrug

    Progesterone administered vaginally at a dose of at least 600 mg/day.

Study groups in NCT00696878
Study groupRoleWhat they receive
Corifollitropin alfa 150 µgExperimentalUp to 3 COS cycles (also called treatment cycles) were performed, each including the following: A single injection of 150 µg corifollitropin alfa was administered on Day 2 or 3 of the menstrual cycle (Stimulation Day 1). Administration of GnRH antagonist (0.25 mg/day) started on Stimulation Day 5 or 6 and continued through day of administration of recombinant Human Chorion Gonadotropin ([rec]hCG) (5,000-10,000 IU/250 µg). Administration of (rec)hCG occurred when 3 follicles ≥17 mm were observed on ultrasound scan (USS). Daily dosing with Follicle Stimulating Hormone (FSH) (not to exceed 225 IU/day) began on Stimulation Day 8 and continued up to day of (rec)hCG administration. Progesterone for luteal phase support was administered starting on the day of oocyte pick-up (34-36 hours after [rec]hCG) and continued for approximately 6 weeks. After COS cycles 1 and 2, Frozen-Thawed Embryo Transfer cycles (up to 3 after each COS cycle) could occur.
Receives: Drug: Corifollitropin alfa; Biological: FSH; Biological: GnRH antagonist; Biological: (rec)hCG; Drug: Progesterone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Clinically Relevant Immunogenicity

    Serum samples obtained pre-dose and at 2 weeks after embryo transfer (ET), or at cycle discontinuation and 2-3 weeks after cycle discontinuation if cycle was stopped before ET was performed, were analyzed for presence of anti-corifollitropin alfa antibodies using screening and confirmatory tests. If a participant was confirmed to have anti-corifollitropin alfa antibody present in a post dose sample according to these tests, review of adverse events (AEs) in the participant was performed. The sample was also tested to evaluate whether the antibody appeared to have neutralizing activity that would interfere with the study drug biological effect. A participant was determined to have clinically relevant immunogenicity if the participant had a confirmed post dose anti-corifollitropin alfa antibody test result accompanied by clinical signs of immunogenicity (e.g., hypersensitivity reaction), considering also the results of the test for neutralizing activity of any antibody present.

    Measured: Pre-dose (Stimulation Day 1) and up to approximately 40 days post dose in each treatment cycle

  2. Local Tolerance at Injection Site: Number of Participants With no Event of Itching and With Mild, Moderate and Severe Itching in Any of 3 Treatment Cycles

    At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results for the assessment of itching. A participant with an event was counted once in this analysis.

    Measured: 30 minutes post dose in each treatment cycle

  3. Local Tolerance at Injection Site: Number of Participants With no Event of Pain and With Mild, Moderate and Severe Pain in Any of 3 Treatment Cycles

    At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results for the assessment of pain. A participant with an event was counted once in this analysis.

    Measured: 30 minutes post dose in each treatment cycle

  4. Local Tolerance at Injection Site: Number of Participants With no Event of Redness and With Mild, Moderate and Severe Redness in Any of 3 Treatment Cycles

    At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results for the assessment of redness. A participant with an event was counted once in this analysis.

    Measured: 30 minutes post dose in each treatment cycle

  5. Local Tolerance at Injection Site: Number of Participants With no Event of Swelling and With Mild, Moderate and Severe Swelling in Any of 3 Treatment Cycles

    At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results for the assessment of swelling. A participant with an event was counted once in this analysis.

    Measured: 30 minutes post dose in each treatment cycle

  6. Local Tolerance at Injection Site Overall Summary: Number of Participants With no Local Tolerance Event (Itching, Pain, Redness or Swelling) and With a Mild, Moderate and Severe Local Tolerance Event in Any of 3 Treatment Cycles

    At 30 minutes after dosing in each treatment cycle, the corifollitropin alfa injection site was assessed for the presence of itching, pain, redness and swelling, each of which was scored as none (no event), mild, moderate or severe. This measure reports results considering the occurrence of any of the defined local tolerance events. A participant with an event was counted once in this analysis.

    Measured: 30 minutes post dose in each treatment cycle

  7. Number of Participants With AEs

    An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

    Measured: Up to approximately 26 months after first dose of corifollitropin alfa

  8. Number of Participants With Serious AEs (SAEs)

    An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. SAEs that occurred in fetuses or infants during the study period are included in this summary of SAEs, and are allocated to the associated study participant who was administered corifollitropin alfa.

    Measured: Up to approximately 26 months after first dose of corifollitropin alfa

  9. Number of Participants With Moderate to Severe Ovarian Hyperstimulation Syndrome (OHSS)

    OHSS was classified on study based on a slightly modified WHO Scientific Group (1973) classification: Grade I (mild) = characterized by excessive steroid secretion and ovarian enlargement (5-7 cm). Abdominal discomfort, including abdominal pain, is present. Grade II (moderate) = characterized by distinct ovarian cysts (ovary size 8-10 cm), accompanied by abdominal pain and tension, nausea, vomiting, diarrhea. Grade III (severe) = characterized by enlarged cystic ovaries (ovary size >10 cm), accompanied by ascites and occasionally hydrothorax. Abdominal tension and pain may be severe. Pronounced hydrothorax together with an abdominal cavity filled with cysts and fluid elevating the diaphragm may cause severe breathing difficulties. Large quantities of fluid inside the cysts and in the peritoneal and pleural cavities cause haemoconcentration and increased blood viscosity. In rare cases, the syndrome may further be complicated by the occurrence of thromboembolic phenomena.

    Measured: Up to approximately 1 month after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), within a treatment cycle

Secondary outcomes (60)

  1. Amount of (Rec)FSH Needed From Stimulation Day 8 Onwards to Reach the Criterion for Administration of (Rec)hCG

    Beginning on Stimulation Day 8 of each treatment cycle, (rec)FSH was administered daily until the criteria for administration of (rec)hCG (presence of 3 follicles ≥17 mm documented by ultrasonography) was reached. The total amount of (rec)FSH administered in each participant to reach the criteria for (rec)hCG administration was calculated.

    Measured: Stimulation Day 8 to day of (rec)hCG administration (approximately Stimulation Day 10), within a treatment cycle

  2. Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 1

    For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.

    Measured: Stimulation Day 1 in Treatment Cycle 1

  3. Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 2

    For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.

    Measured: Stimulation Day 1 in Treatment Cycle 2

  4. Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 1 During Treatment Cycle 3

    For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.

    Measured: Stimulation Day 1 in Treatment Cycle 3

  5. Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 5 or 6 During Treatment Cycle 1

    For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.

    Measured: Stimulation Day 5 or 6 in Treatment Cycle 1

  6. Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 5 or 6 During Treatment Cycle 2

    For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.

    Measured: Stimulation Day 5 or 6 in Treatment Cycle 2

  7. Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 5 or 6 During Treatment Cycle 3

    For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.

    Measured: Stimulation Day 5 or 6 in Treatment Cycle 3

  8. Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 8 During Treatment Cycle 1

    For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.

    Measured: Stimulation Day 8 in Treatment Cycle 1

  9. Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 8 During Treatment Cycle 2

    For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.

    Measured: Stimulation Day 8 in Treatment Cycle 2

  10. Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Stimulation Day 8 During Treatment Cycle 3

    For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on defined days during the treatment cycle was calculated.

    Measured: Stimulation Day 8 in Treatment Cycle 3

  11. Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Day of (Rec)hCG Administration During Treatment Cycle 1

    For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on the day of (rec)hCG administration during the treatment cycle was recorded.

    Measured: Day of (rec)hCG administration (approximately Stimulation Day 10) in Treatment Cycle 1

  12. Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Day of (Rec)hCG Administration During Treatment Cycle 2

    For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on the day of (rec)hCG administration during the treatment cycle was recorded.

    Measured: Day of (rec)hCG administration (approximately Stimulation Day 10) in Treatment Cycle 2

  13. Number of Follicles ≥11 mm, ≥15 mm and ≥17 mm Documented by Ultrasonography Performed in the Participant on Day of (Rec)hCG Administration During Treatment Cycle 3

    For each participant, the number of follicles ≥11 mm, ≥15 mm and ≥17 mm documented by ultrasonography on the day of (rec)hCG administration during the treatment cycle was recorded.

    Measured: Day of (rec)hCG administration (approximately Stimulation Day 10) in Treatment Cycle 3

  14. Number of Oocytes Retrieved in a Participant Among Entire Study Population

    Oocyte retrieval, also known as oocyte pick-up, is a technique used in in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) in order to remove oocytes from the ovary of the female, enabling fertilization outside the body. The number of oocytes retrieved, per participant, is summarized.

    Measured: Day of oocyte pick-up, 34-36 hours after (rec)hCG administration (approximately Stimulation Day 10), within a treatment cycle

  15. Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 1

    This measure summarizes results of assessment of the quality of oocytes performed following oocyte retrieval, among participants scheduled for ICSI in Treatment Cycle 1. For oocytes obtained from each participant, the number in each of 3 stages of oocyte development were determined. The earliest phase is the germinal vesicles stage, during which the immature oocyte appears as a large vesicular nucleus. Metaphase I is an intermediate stage during which the vesicles have broken down and the polar body has not yet formed; the oocyte is still immature. Metaphase II is the mature oocyte and is indicated by the presence of the polar body. Rating of quality for usefulness in ICSI follows the order metaphase II (best quality), metaphase I (lesser quality) and germinal vesicles stage (poorest quality). Only metaphase II oocytes can be fertilized. Metaphase I oocytes can develop in vitro to metaphase II oocytes. Germinal vesicles stage oocytes are the least useful for ICSI procedures.

    Measured: Day of oocyte pick-up, 34-36 hours after (rec)hCG administration (approximately Stimulation Day 10), in Treatment Cycle 1

  16. Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 2

    This measure summarizes results of assessment of the quality of oocytes performed following oocyte retrieval, among participants scheduled for ICSI in Treatment Cycle 2. For oocytes obtained from each participant, the number in each of 3 stages of oocyte development were determined. The earliest phase is the germinal vesicles stage, during which the immature oocyte appears as a large vesicular nucleus. Metaphase I is an intermediate stage during which the vesicles have broken down and the polar body has not yet formed; the oocyte is still immature. Metaphase II is the mature oocyte and is indicated by the presence of the polar body. Rating of quality for usefulness in ICSI follows the order metaphase II (best quality), metaphase I (lesser quality) and germinal vesicles stage (poorest quality). Only metaphase II oocytes can be fertilized. Metaphase I oocytes can develop in vitro to metaphase II oocytes. Germinal vesicles stage oocytes are the least useful for ICSI procedures.

    Measured: Day of oocyte pick-up, 34-36 hours after (rec)hCG administration (approximately Stimulation Day 10), in Treatment Cycle 2

  17. Quality of Oocytes Assessed Prior to Planned ICSI in Treatment Cycle 3

    This measure summarizes results of assessment of the quality of oocytes performed following oocyte retrieval, among participants scheduled for ICSI in Treatment Cycle 3. For oocytes obtained from each participant, the number in each of 3 stages of oocyte development were determined. The earliest phase is the germinal vesicles stage, during which the immature oocyte appears as a large vesicular nucleus. Metaphase I is an intermediate stage during which the vesicles have broken down and the polar body has not yet formed; the oocyte is still immature. Metaphase II is the mature oocyte and is indicated by the presence of the polar body. Rating of quality for usefulness in ICSI follows the order metaphase II (best quality), metaphase I (lesser quality) and germinal vesicles stage (poorest quality). Only metaphase II oocytes can be fertilized. Metaphase I oocytes can develop in vitro to metaphase II oocytes. Germinal vesicles stage oocytes are the least useful for ICSI procedures.

    Measured: Day of oocyte pick-up, 34-36 hours after (rec)hCG administration (approximately Stimulation Day 10), in Treatment Cycle 3

  18. Number of Fertilized Oocytes Obtained in Treatment Cycle 1

    This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure, by category of number of pronuclei (PN) present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).

    Measured: 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1

  19. Number of Fertilized Oocytes Obtained in Treatment Cycle 2

    This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).

    Measured: 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2

  20. Number of Fertilized Oocytes Obtained in Treatment Cycle 3

    This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).

    Measured: 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3

  21. Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 1

    This measure presents the number of fertilized oocytes obtained per participant from the IVF or ICSI procedure that were cryopreserved (frozen) for possible later use, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).

    Measured: 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1

  22. Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 2

    This measure presents the number of fertilized oocytes obtained per participant from the IVF or ICSI procedure that were cryopreserved (frozen) for possible later use, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).

    Measured: 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2

  23. Number of Fertilized Oocytes Obtained That Were Frozen in Treatment Cycle 3

    This measure presents the number of fertilized oocytes obtained per participant from the IVF or ICSI procedure that were cryopreserved (frozen) for possible later use, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).

    Measured: 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3

  24. Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 1

    This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure that were used for embryo development, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).

    Measured: 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1

  25. Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 2

    This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure that were used for embryo development, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).

    Measured: 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2

  26. Number of Fertilized Oocytes Obtained That Were Used for Embryo Development in Treatment Cycle 3

    This measure presents the number of fertilized oocytes obtained per participant from the IVF or ISCI procedure that were used for embryo development, by category of number of PN present: 0 PN, 1 PN, 2 PN, ≥3 PN, other (fertilized oocyte that was not placed in PN category). Normal fertilized ooctyes have 2 pronuclei (2 PN).

    Measured: 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3

  27. Fertilization Rate

    The fertilization rate (in percent) is defined as 100 times the ratio of the number of fertilized 2 PN oocytes obtained and the number of oocytes that was used for fertilization, per participant.

    Measured: 16-18 hours after start of IVF or ICSI, which occurs on day of oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), within a treatment cycle

  28. Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 1

    At Day 3 after oocyte pick-up, embryos obtained from IVF or ISCI process for each participant were counted and quality was assessed. Quality was rated as Grade 1, 2 or 3, or "other grade", with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of "good quality."

    Measured: Day 3 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1

  29. Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 2

    At Day 3 after oocyte pick-up, embryos obtained from IVF or ISCI process for each participant were counted and quality was assessed. Quality was rated as Grade 1, 2 or 3, or "other grade", with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of "good quality."

    Measured: Day 3 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2

  30. Number and Quality of Embryos Obtained at Day 3 After Oocyte Pick-up in Treatment Cycle 3

    At Day 3 after oocyte pick-up, embryos obtained from IVF or ISCI process for each participant were counted and quality was assessed. Quality was rated as Grade 1, 2 or 3, or "other grade", with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of "good quality."

    Measured: Day 3 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3

  31. Number of Embryos Transferred

    ET is the procedure in which one or more embryos are placed in the uterus. The number of embryos transferred, per participant, is summarized.

    Measured: At ET, Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), within a treatment cycle

  32. Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 1

    The number of embryos transferred, for each participant, by category of number of "good quality" embryos transferred, is summarized. Quality was rated as Grade 1, 2 or 3, or "other grade", with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of "good quality."

    Measured: At ET, Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1

  33. Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 2

    The number of embryos transferred, for each participant, by category of number of "good quality" embryos transferred, is summarized. Quality was rated as Grade 1, 2 or 3, or "other grade", with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of "good quality."

    Measured: At ET, Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2

  34. Number of Participants by Category of Number of Good Quality Embryos Transferred in Treatment Cycle 3

    The number of embryos transferred, for each participant, by category of number of "good quality" embryos transferred, is summarized. Quality was rated as Grade 1, 2 or 3, or "other grade", with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of "good quality."

    Measured: At ET, Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3

  35. Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 1

    The number of embryos that were cryopreserved (frozen) for possible later use, for each participant, overall and by embryo quality categories, is summarized. Quality was rated as Grade 1, 2 or 3, or "other grade", with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of "good quality."

    Measured: Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 1

  36. Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 2

    The number of embryos that were cryopreserved (frozen) for possible later use, for each participant, overall and by embryo quality categories, is summarized. Quality was rated as Grade 1, 2 or 3, or "other grade", with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of "good quality."

    Measured: Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 2

  37. Number and Quality of Embryos Obtained That Were Frozen in Treatment Cycle 3

    The number of embryos that were cryopreserved (frozen) for possible later use, for each participant, overall and by embryo quality categories, is summarized. Quality was rated as Grade 1, 2 or 3, or "other grade", with Grade 1 representing the best quality. The 2 highest quality grades (Grade 1 + 2) were combined into a summary category of "good quality."

    Measured: Day 3 or Day 5 after oocyte pick-up (34-36 hours after [rec]hCG administration [approximately Stimulation Day 10]), in Treatment Cycle 3

  38. Implantation Rate for Participants With ET

    The implantation rate (in percent) is defined as 100 times the maximum number of gestational sacs as assessed by any ultrasound scan after ET divided by the number of embryos transferred per participant.

    Measured: Approximately 5-6 weeks after ET, within a treatment cycle

  39. Number of Participants With Biochemical Pregnancy, Clinical Pregnancy, Vital Pregnancy and Ongoing Pregnancy in Any of Treatment Cycles 1, 2 or 3

    Biochemical pregnancy: Pregnancy proven by a biochemical pregnancy test using urine samples or serum samples collected at least 14 days after ET. Participants not having a positive biochemical pregnancy test result, but with an ultrasound scan showing at least one gestational sac were counted as having a biochemical pregnancy. Clinical pregnancy: Presence of at least one gestational sac as assessed by ultrasound scan. Vital pregnancy: Presence of at least one fetus with heart activity as assessed by ultrasound scan. Ongoing pregnancy: Presence of at least one fetus with heart activity as assessed by ultrasound scan at least 10 weeks after ET, or confirmed by live birth.

    Measured: ≥14 days (for biochemical pregnancy), 5-6 weeks (for clinical pregnancy), 5-6 weeks to 10 weeks (for vital pregnancy) and 10 weeks up to 9 months (for ongoing pregnancy) after ET, within a treatment cycle

  40. Number of Participants With Singleton and Multiple Ongoing Pregnancy in Any of Treatment Cycles 1, 2 or 3

    Singleton pregnancy is a pregnancy in which one fetus develops in the uterus. Multiple pregnancy is a pregnancy in which more than one fetus develops simultaneously in the uterus. Ongoing pregnancy: Presence of at least one fetus with heart activity as assessed by ultrasound scan at least 10 weeks after ET, or confirmed by live birth.

    Measured: 10 weeks up to 9 months after ET, within a treatment cycle

  41. Number of Participants With Miscarriage Among Participants With Clinical Pregnancy in Any of Treatment Cycles 1, 2 or 3

    Miscarriage: Loss of the fetus without induction or instrumentation, also known as "spontaneous abortion." Clinical pregnancy: Presence of at least one gestational sac as assessed by ultrasound scan.

    Measured: 5-6 weeks up to 9 months after ET, within a treatment cycle

  42. Number of Participants With Miscarriage Among Participants With Vital Pregnancy in Any of Treatment Cycles 1, 2 or 3

    Miscarriage: Loss of the fetus without induction or instrumentation, also known as "spontaneous abortion." Vital pregnancy: Presence of at least one fetus with heart activity as assessed by ultrasound scan.

    Measured: 5-6 weeks up to 9 months after ET, within a treatment cycle

  43. Number of Participants With Ectopic Pregnancy Among Participants With Biochemical Pregnancy in Any of Treatment Cycles 1, 2 or 3

    Ectopic pregnancy: A pregnancy in which the embryo attaches itself in a place other than inside the uterus. The most common site for an ectopic pregnancy is within one of the two fallopian tubes. Biochemical pregnancy: Pregnancy proven by a biochemical pregnancy test using urine samples or serum samples collected at least 14 days after ET. Participants not having a positive biochemical pregnancy test result, but with an ultrasound scan showing at least one gestational sac were counted as having a biochemical pregnancy.

    Measured: From 2 weeks up to approximately 5-6 weeks after ET, within a treatment cycle

  44. Number of Participants With Ongoing Pregnancy in Any FTET Cycle

    After the first and after the second treatment cycle (i.e., a cycle in which corifollitropin alfa was administered for ovarian stimulation), participants could continue with a maximum of three FTET cycles before starting the following treatment cycle. This measure summarizes the number of participants with ongoing pregnancy following ET within an FTET cycle. Ongoing pregnancy: Presence of at least one fetus with heart activity as assessed by ultrasound scan at least 10 weeks after ET, or confirmed by live birth.

    Measured: 10 weeks up to 9 months after ET within an FTET cycle

  45. Cumulative Ongoing Pregnancy Rate: Percentage of Participants With Ongoing Pregnancy in Treatment Cycles 1, 2 or 3, or in Any FTET Cycle, or Who Had Ongoing Pregnancy That Was a Spontaneous Pregnancy

    The ongoing pregnancy rate, cumulative over the entire study (in percent), is defined as 100 times the number of participants who had an ongoing pregnancy in Treatment Cycles 1, 2 or 3, or in any FTET cycle, or who had a spontaneous ongoing pregnancy, divided by the total number of participants who were administered corifollitropin alfa in the study. A participant could only be represented once in the count of ongoing pregnancies for determination of cumulative ongoing pregnancy rate. After the first and after the second treatment cycle (i.e., a cycle in which corifollitropin alfa was administered for ovarian stimulation), participants could continue with a maximum of three FTET cycles before starting the following treatment cycle. A spontaneous pregnancy is a pregnancy that was not considered to have resulted from ET in a treatment cycle or FTET cycle.

    Measured: Up to approximately 26 months after first dose of corifollitropin alfa

  46. Serum Follicle Stimulating Hormone (FSH) Levels in Treatment Cycle 1

    Blood samples for assessment of serum FSH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.

    Measured: Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 1

  47. Serum FSH Levels in Treatment Cycle 2

    Blood samples for assessment of serum FSH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.

    Measured: Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 2

  48. Serum FSH Levels in Treatment Cycle 3

    Blood samples for assessment of serum FSH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.

    Measured: Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 3

  49. Serum Luteinizing Hormone (LH) Levels in Treatment Cycle 1

    Blood samples for assessment of serum LH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.

    Measured: Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 1

  50. Serum LH Levels in Treatment Cycle 2

    Blood samples for assessment of serum LH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.

    Measured: Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 2

  51. Serum LH Levels in Treatment Cycle 3

    Blood samples for assessment of serum LH were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.

    Measured: Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 3

  52. Serum Estradiol Levels in Treatment Cycle 1

    Blood samples for assessment of serum estradiol were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.

    Measured: Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 1

  53. Serum Estradiol Levels in Treatment Cycle 2

    Blood samples for assessment of serum estradiol were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.

    Measured: Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 2

  54. Serum Estradiol Levels in Treatment Cycle 3

    Blood samples for assessment of serum estradiol were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.

    Measured: Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 3

  55. Serum Progesterone Levels in Treatment Cycle 1

    Blood samples for assessment of serum progesterone were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.

    Measured: Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 1

  56. Serum Progesterone Levels in Treatment Cycle 2

    Blood samples for assessment of serum progesterone were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.

    Measured: Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 2

  57. Serum Progesterone Levels in Treatment Cycle 3

    Blood samples for assessment of serum progesterone were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.

    Measured: Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 3

  58. Serum Inhibin-B Levels in Treatment Cycle 1

    Blood samples for assessment of serum inhibin-B were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.

    Measured: Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 1

  59. Serum Inhibin-B Levels in Treatment Cycle 2

    Blood samples for assessment of serum inhibin-B were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.

    Measured: Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 2

  60. Serum Inhibin-B Levels in Treatment Cycle 3

    Blood samples for assessment of serum inhibin-B were taken pre-dose (Stimulation Day 1), Stimulation Day 5 or 6 (prior to first GnRH antagonist administration), Stimulation Day 8, day of (rec)hCG administration, day of ET and 2 weeks after ET.

    Measured: Pre-dose (Stimulation Day 1) through 2 weeks after ET in Treatment Cycle 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2008 (estimated)
  2. Study start26 Sep 2006
  3. Primary completion17 Feb 2009
  4. Study completion15 May 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
682 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00696878
Sponsor's protocol ID
P05714
Other IDs
MK-8962-007, 38825, 2004-004966-34, 2004
Acronym
Trust
Status last verified
Feb 2022
First submitted
11 Jun 2008
Last updated
18 Jun 2024
Data monitoring committee
No
Individual data sharing
No

Publications

  • Zandvliet AS, Prohn M, de Greef R, van Aarle F, McCrary Sisk C, Stegmann BJ. Impact of patient characteristics on the pharmacokinetics of corifollitropin alfa during controlled ovarian stimulation. Br J Clin Pharmacol. 2016 Jul;82(1):74-82. doi: 10.1111/bcp.12939. Epub 2016 May 31.

    PubMed 26991902

  • Griesinger G, Verweij PJ, Gates D, Devroey P, Gordon K, Stegmann BJ, Tarlatzis BC. Prediction of Ovarian Hyperstimulation Syndrome in Patients Treated with Corifollitropin alfa or rFSH in a GnRH Antagonist Protocol. PLoS One. 2016 Mar 7;11(3):e0149615. doi: 10.1371/journal.pone.0149615. eCollection 2016.

    PubMed 26950065

  • Rombauts L, Lambalk CB, Schultze-Mosgau A, van Kuijk J, Verweij P, Gates D, Gordon K, Griesinger G. Intercycle variability of the ovarian response in patients undergoing repeated stimulation with corifollitropin alfa in a gonadotropin-releasing hormone antagonist protocol. Fertil Steril. 2015 Oct;104(4):884-890.e2. doi: 10.1016/j.fertnstert.2015.06.027. Epub 2015 Jul 15.

    PubMed 26187300

  • Norman RJ, Zegers-Hochschild F, Salle BS, Elbers J, Heijnen E, Marintcheva-Petrova M, Mannaerts B; Trust Investigators. Repeated ovarian stimulation with corifollitropin alfa in patients in a GnRH antagonist protocol: no concern for immunogenicity. Hum Reprod. 2011 Aug;26(8):2200-8. doi: 10.1093/humrep/der163. Epub 2011 May 27.

    PubMed 21622693

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Corifollitropin alfa, FSH and GnRH antagonist in people with In Vitro Fertilization, run by Organon and Co.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Clinically Relevant Immunogenicity (time frame: Pre-dose (Stimulation Day 1) and up to approximately 40 days post dose in each treatment cycle). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00696878, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.

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