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Controlled Ovarian SimulationPhase 3NCT03296527

Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Pan-Asian Women

A Phase 3 study testing Follitropin alfa and Follitropin delta in people with Controlled Ovarian Simulation, run by Ferring Pharmaceuticals at 26 sites in 4 countries.

Completed

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

Official record
Search all trials

Trial summary

To demonstrate non-inferiority of FE 999049 compared with GONAL-F with respect to ongoing pregnancy rate in women undergoing controlled ovarian stimulation. Read more about this study

Who is it for?
Ages 20 to 40 years, women only
Conditions the study is for
Controlled Ovarian Simulation
What is being tested?
Follitropin alfa and Follitropin delta
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,011 participants
Where
26 sitesin 4 countries
Study dates
1 Dec 2017to 26 Jul 2020
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 20 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Informed Consent Documents signed prior to screening evaluations.
  • In good physical and mental health in the judgement of the investigator.
  • Asian pre-menopausal females between the ages of 20 and 40 years. The participants must be at least 20 years (including the 20th birthday) when they sign the informed consent and no more than 40 years (up to the day before the 41st birthday) at the time of randomization.
  • Infertile women diagnosed with tubal infertility, unexplained infertility, endometriosis stage I/II (defined by the revised American Society for Reproductive Medicine [ASRM] classification, 1996) or with partners diagnosed with male factor infertility, eligible for in vitro fertilisation (IVF) and/or intracytoplasmic sperm injection (ICSI) using fresh or frozen ejaculated sperm from male partner or sperm donor.
  • Infertility for at least one year before randomization for participants <35 years or for at least 6 months for participants ≥35 years (not applicable in case of tubal or severe male factor infertility).
  • The trial cycle will be the participant's first controlled ovarian stimulation cycle for IVF/ICSI.
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  • Regular menstrual cycles of 24-35 days (both inclusive), presumed to be ovulatory.
  • Hysterosalpingography, hysteroscopy, saline infusion sonography, or transvaginal ultrasound documenting a uterus consistent with expected normal function (e.g. no evidence of clinically interfering uterine fibroids defined as submucous or intramural fibroids larger than 3 cm in diameter, no polyps and no congenital structural abnormalities which are associated with a reduced chance of pregnancy) within 1 year prior to randomization.
  • Transvaginal ultrasound documenting presence and adequate visualisation of both ovaries, without evidence of significant abnormality (e.g. enlarged ovaries which would contraindicate the use of gonadotropins) and normal adnexa (e.g. no hydrosalpinx) within 1 year prior to randomization. Both ovaries must be accessible for oocyte retrieval.
  • Early follicular phase (cycle day 2-4) serum levels of FSH between 1 and 15 IU/L (results obtained within 3 months prior to randomization).
  • Negative serum Hepatitis B Surface Antigen (HBsAg), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) antibody tests within 2 years prior to randomization.
  • Body mass index (BMI) between 17.5 and 32.0 kg/m2 (both inclusive) at screening.
  • Willing to accept transfer of 1-2 embryos.

Who cannot join

  • Known endometriosis stage III-IV (defined by the revised ASRM classification, 1996).
  • One or more follicles ≥10 mm (including cysts) observed on the transvaginal ultrasound prior to randomization on stimulation day 1 (puncture of cysts is allowed prior to randomization).
  • Known history of recurrent miscarriage (defined as three consecutive losses after ultrasound confirmation of pregnancy (excl. ectopic pregnancy) and before week 24 of pregnancy).
  • Known abnormal karyotype of participant or of her partner / sperm donor, as applicable, depending on source of sperm used for insemination in this trial.
  • Any known clinically significant systemic disease (e.g. insulin-dependent diabetes).
  • Known inherited or acquired thrombophilia disease.
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  • Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events.
  • Known porphyria.
  • Any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) with the exception of controlled thyroid function disease.
  • Known presence of anti-FSH antibodies (based on the information available in the participant's medical records; i.e. not based on the anti-FSH antibody analyses conducted in the trial).
  • Known tumours of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus which would contraindicate the use of gonadotropins.
  • Known moderate or severe impairment of renal or hepatic function.
  • Any abnormal finding of clinical chemistry, haematology or vital signs at screening which is clinically significant as judged by the investigator.
  • Currently breast-feeding.
  • Undiagnosed vaginal bleeding.
  • Known abnormal cervical cytology of clinical significance observed within three years prior to randomization (unless the clinical significance has been resolved).
  • Findings at the gynaecological examination at screening which preclude gonadotropin stimulation or are associated with a reduced chance of pregnancy, e.g. congenital uterine abnormalities or retained intrauterine device.
  • Pregnancy (negative urinary pregnancy tests must be documented at screening and prior to randomization) or contraindication to pregnancy.
  • Known current active pelvic inflammatory disease.
  • Use of fertility modifiers during the last menstrual cycle before randomization, including dehydroepiandrosterone (DHEA), metformin or cycle programming with oral contraceptives, progestogen or estrogen preparations.
  • Use of hormonal preparations (except for thyroid medication) during the last menstrual cycle before randomization.
  • Known history of chemotherapy (except for gestational conditions) or radiotherapy.
  • Current or past (1 year prior to randomization) abuse of alcohol or drugs.
  • Current (last month) intake of more than 14 units of alcohol per week.
  • Current or past (3 months prior to randomization) smoking habit of more than 10 cigarettes per day.
  • Hypersensitivity to any active ingredient or excipients in the medicinal products used in the trial.
  • Previous participation in the trial.
  • Use of any non-registered investigational drugs during the last 3 months prior to randomization.

Trial locations and contacts

26 sites in 4 countries.

26 sites in 4 countries

China16 sites

  • Beijing Obstetrics and Gynecology Hospital,Capital Medical University

    Beijing

  • Medical Center for Human Reproduction, Peking University Third Hospital

    Beijing

  • Peking University First Hospital

    Beijing

  • West China Second University Hospital of Sichuan University

    Chengdu

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou

  • The Sixth Affiliated Hospital of Sun Yat-sen University

    Guangzhou

  • The Third Affiliated Hospital of Guangzhou Medical University

    Guangzhou

  • The First Affiliated Hospital of An'hui Medical University

    Hefei

  • Jiangsu Province Hospital

    Nanjing

  • ShengJing Hospital of China Medical University

    Shenyang

  • Peking University Shenzhen Hospital

    Shenzhen

  • Tianjin Central Hospital of Gynaecology and Obstetrics

    Tianjin

  • Tianjin Medical University General Hospital

    Tianjin

  • Renmin Hospital of Wuhan University

    Wuhan

  • Tongji Hospital,Tongji Medical College, Huazhong University of Science & Technology

    Wuhan

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

Other trials in China

South Korea4 sites

  • Seoul National University Bundang Hospital

    Seongnam-si

  • Asan Medical Center

    Seoul

  • Samsung Medical Center

    Seoul

  • Seoul National University Hospital

    Seoul

Other trials in South Korea

Taiwan4 sites

  • Taichung Veterans General Hospital

    Taichung

  • National Taiwan University Hospital

    Taipei

  • Taipei Medical University Hospital

    Taipei

  • Chang Gung Memorial Hospital

    Taoyuan

Other trials in Taiwan

Vietnam2 sites

  • National Center for Assisted Reproductive Technology

    Hanoi

  • My Duc Hospital

    Ho Chi Minh City

Other trials in Vietnam

About this study

Official title: A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre, Pan-Asian Trial Comparing the Efficacy and Safety of FE 999049 With Follitropin Alfa (GONAL-F) in Controlled Ovarian Stimulation in Women Undergoing Assisted Reproductive Technology Programme

To demonstrate non-inferiority of FE 999049 compared with GONAL-F with respect to ongoing pregnancy rate in women undergoing controlled ovarian stimulation.

Being tested
Follitropin alfa, Follitropin delta

What participants receive

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

  • Follitropin alfaDrug

    Also called GONAL-F

    GONAL-F dose was fixed for the first 5 stimulation days.

  • Follitropin deltaDrug

    Also called FE 999049, REKOVELLE

    REKOVELLE (FE 999049) was fixed throughout the stimulation period.

Study groups in NCT03296527
Study groupRoleWhat they receive
Follitropin deltaExperimentalRecombinant follicle-stimulating hormone (rFSH). Follitropin delta for subcutaneous injection
Receives: Drug: Follitropin delta
Gonal-FActive comparatorrFSH. Follitropin alfa for subcutaneous injection
Receives: Drug: Follitropin alfa

What is being measured

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

  1. Ongoing Pregnancy Rate

    Defined as at least one intrauterine viable fetus 10-11 weeks after transfer.

    Measured: 10-11 weeks after transfer

Secondary outcomes (60)

  1. Positive Beta Unit of Human Chorionic Gonadotropin (βhCG) Rate

    Defined as positive βhCG test 13-15 days after transfer.

    Measured: 13-15 days after transfer

  2. Clinical Pregnancy Rate

    Defined as at least one gestational sac 5-6 weeks after transfer.

    Measured: 5-6 weeks after transfer

  3. Vital Pregnancy Rate

    Defined as at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after transfer.

    Measured: 5-6 weeks after transfer

  4. Implantation Rate

    Defined as number of gestational sacs 5-6 weeks after transfer divided by number of embryos transferred.

    Measured: 5-6 weeks after transfer

  5. Ongoing Implantation Rate

    Defined as number of intrauterine viable fetuses 10-11 weeks after transfer divided by number of embryos transferred.

    Measured: 10-11 weeks after transfer

  6. Proportion of Subjects With Extreme Ovarian Responses

    Extreme ovarian response defined as <4, ≥15 or ≥ 20 oocytes retrieved. Participants with cycle cancellation due to poor ovarian response are included as <4 oocytes retrieved.

    Measured: Oocyte retrieval visit

  7. Proportion of Subjects With Early OHSS (Including OHSS of Moderate/Severe Grade) and/or Preventive Interventions for Early OHSS

    Early OHSS was defined as OHSS with onset ≤9 days after triggering of final follicular maturation. Classification of grade was according to Golan's classification system, and all OHSS cases were graded as mild, moderate or severe.

    Measured: Up to 9 days after triggering of final follicular maturation

  8. Proportion of Subjects With Cycle Cancellation Due to Poor or Excessive Ovarian Response or Embryo Transfer Cancellation Due to Excessive Ovarian Response / OHSS Risk

    For each participant the reason for each cycle cancellation was recorded. Embryo transfer cancellation due to adverse events, such as ovarian hyperfunction, OHSS and progesterone increased in participants with embryos available for transfer, were considered as transfer cancellations due to excessive response / OHSS risk.

    Measured: End-of-stimulation visit (up to 20 days) or transfer visit

  9. Number of Follicles on Stimulation Day 6

    Counted by ultrasound for the right and left ovary for each participant.

    Measured: On stimulation Day 6

  10. Number of Follicles At End-of-stimulation (up to 20 Stimulation Days)

    Counted by ultrasound for the right and left ovary for each participant.

    Measured: At end-of-stimulation (up to 20 stimulation days)

  11. Size of Follicles on Stimulation Day 6

    Counted by ultrasound for the right and left ovary for each participant.

    Measured: On stimulation Day 6

  12. Size of Follicles At End-of-stimulation (up to 20 Stimulation Days)

    Counted by ultrasound for the right and left ovary for each participant.

    Measured: At end-of-stimulation (up to 20 stimulation days)

  13. Number of Oocytes Retrieved

    The number of oocytes retrieved was recorded at the oocyte retrieval visit.

    Measured: On the day of oocyte retrieval (36 h [±2h] after triggering of final follicular maturation)

  14. Proportion of Subjects With <4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved

    Grouped according to the number of oocytes retrieved. Participants with cycle cancellation due to poor ovarian response are included in the <4 oocytes group.

    Measured: On the day of oocyte retrieval

  15. Percentage of Metaphase II (MII) Oocytes

    The percentage of MII oocytes to oocytes retrieved for participants where all oocytes were inseminated using intracytoplasmic sperm injection (ICSI) are presented.

    Measured: Prior to insemination

  16. Fertilization Rate

    The fertilization rate was defined as the number of oocytes with 2 pronuclei divided by the number of oocytes retrieved.

    Measured: On Day 1 after oocyte retrieval

  17. Number and Quality of Embryos

    Number of embryos (total and good-quality) on Day 3 are presented. A good-quality embryo was defined as an embryo with ≥6 blastomeres and ≤20% fragmentation, without signs of multinucleation.

    Measured: On Day 3 after oocyte retrieval

  18. Circulating Concentrations of Luteinizing Hormone (LH)

    Blood samples for analysis of circulating concentrations of LH were drawn. The median and inter-quartile range (IQR) of LH levels on stimulation Day 6 are presented.

    Measured: On stimulation Day 6

  19. Circulating Concentrations of LH

    Blood samples for analysis of circulating concentrations of LH were drawn. The median and IQR of LH levels at end-of-stimulation are presented.

    Measured: End-of-stimulation (up to 20 stimulation days)

  20. Circulating Concentrations of Estradiol

    Blood samples for analysis of circulating concentrations of estradiol were drawn. The median and IQR of estradiol levels on stimulation Day 6 are presented.

    Measured: On stimulation Day 6

  21. Circulating Concentrations of Estradiol

    Blood samples for analysis of circulating concentrations of estradiol were drawn. The median and IQR of estradiol levels at end-of-stimulation are presented.

    Measured: End-of-stimulation (up to 20 stimulation days)

  22. Circulating Concentrations of Progesterone

    Blood samples for analysis of circulating concentrations of progesterone were drawn. The median and IQR of progesterone levels on stimulation Day 6 are presented.

    Measured: On stimulation Day 6

  23. Circulating Concentrations of Progesterone

    Blood samples for analysis of circulating concentrations of progesterone were drawn. The median and IQR of progesterone levels at end-of-stimulation are presented.

    Measured: End-of-stimulation (up to 20 stimulation days)

  24. Circulating Concentrations of Inhibin A

    Blood samples for analysis of circulating concentrations of inhibin A. The median and IQR of inhibin A levels on stimulation Day 6 are presented.

    Measured: On stimulation Day 6

  25. Circulating Concentrations of Inhibin A

    Blood samples for analysis of circulating concentrations of inhibin A were drawn. The median and IQR of inhibin A levels at end-of-stimulation are presented.

    Measured: End-of-stimulation (up to 20 stimulation days)

  26. Circulating Concentrations of Inhibin B

    Blood samples for analysis of circulating concentrations of Inhibin B were drawn. The median and IQR of inhibin B levels on stimulation Day 6 are presented.

    Measured: On stimulation Day 6

  27. Circulating Concentrations of Inhibin B

    Blood samples for analysis of circulating concentrations of Inhibin B were drawn. The median and IQR of inhibin B levels at end-of-stimulation are presented.

    Measured: End-of-stimulation (up to 20 stimulation days)

  28. Circulating Concentrations of Follicle-stimulating Hormone (FSH)

    Blood samples for analysis of circulating concentrations of FSH were drawn. The median and IQR of FSH levels on stimulation Day 6 are presented.

    Measured: On stimulation Day 6

  29. Circulating Concentrations of FSH

    Blood samples for analysis of circulating concentrations of FSH were drawn. The median and IQR of FSH levels at end-of-stimulation are presented.

    Measured: End-of-stimulation (up to 20 stimulation days)

  30. Circulating Concentrations of FSH

    Blood samples for analysis of circulating concentrations of FSH were drawn. The median and IQR of FSH levels at oocyte retrieval are presented.

    Measured: At oocyte retrieval

  31. Total Gonadotropin Dose

    Calculated by start dates, end dates and daily dose of IMP.

    Measured: Up to 20 stimulation days

  32. Proportion of Subjects With Investigator-requested Gonadotropin Dose Adjustments

    Investigator-requested decreases and increases of the gonadotropin dose were captured during the stimulation period.

    Measured: Up to 20 stimulation days

  33. Number of Stimulation Days

    Calculated by start dates and end dates.

    Measured: Up to 20 stimulation days

  34. Number of Participants With Adverse Events

    Any adverse event occurring after start of IMP and before the end-of-trial visit, or a pre-treatment adverse event or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit was considered treatment-emergent, and is presented for this endpoint.

    Measured: From screening up to end-of-trial (up to approximately 5.5 months)

  35. Intensity of Adverse Events

    The intensity of adverse event was classified using the following 3-point scale: mild = awareness of signs or symptoms, but no disruption of usual activity; moderate = event sufficient to affect usual activity (disturbing); or severe = inability to work or perform usual activities (unacceptable).

    Measured: From screening up to end-of-trial (up to approximately 5.5 months)

  36. Changes From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase and Gamma Glutamyl Transferase

    Blood samples were collected for the analysis of clinical chemistry parameters including: Alanine aminotransferase, Alkaline phosphatase, Aspartate aminotransferase and Gamma glutamyl transferase.

    Measured: From screening up to end-of-trial (up to approximately 5.5 months)

  37. Change From Baseline in Clinical Chemistry Parameters: Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium and Sodium

    Blood samples were collected for the analysis of clinical chemistry parameters including: Bicarbonate, Blood urea nitrogen, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium and Sodium.

    Measured: From screening up to end-of-trial (approximately 5.5 months)

  38. Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein

    Blood samples were collected for the analysis of clinical chemistry parameters including: Albumin and Protein.

    Measured: From screening up to end-of-trial (approximately 5.5 months)

  39. Change From Baseline in Clinical Chemistry Parameter: Lactate Dehydrogenase

    Blood samples were collected for the analysis of clinical chemistry parameter including: Lactate dehydrogenase.

    Measured: From screening up to end-of-trial (approximately 5.5 months)

  40. Change From Baseline in Clinical Chemistry Parameter: Direct Bilirubin, Bilirubin, Creatinine, Urate

    Blood samples were collected for the analysis of clinical chemistry parameter including: Direct bilirubin, Bilirubin, Creatinine, Urate.

    Measured: From screening up to end-of-trial (approximately 5.5 months)

  41. Proportion of Subjects With Markedly Abnormal Changes of Clinical Chemistry: Alanine Aminotransferase, Aspartate Aminotransferase, Bicarbonate, Calcium, Phosphate

    The table represents the percentage of participants in each group with normal baseline values and markedly abnormal end-of-stimulation or end-of-trial values for alanine aminotransferase, aspartate aminotransferase, bicarbonate, calcium, phosphate.

    Measured: End-of-stimulation visit and end-of-trial visit

  42. Change From Baseline in Haematology Parameter: Erythrocytes

    Blood samples were collected for the analysis of haematology parameter including: Erythrocytes.

    Measured: From screening up to end-of-trial (approximately 5.5 months)

  43. Change From Baseline in Haematology Parameters: Leukocytes and Platelets

    Blood samples were collected for the analysis of haematology parameters including: Leukocytes and Platelets.

    Measured: From screening up to end-of-trial (approximately 5.5 months)

  44. Change From Baseline in Haematology Parameter: Haemoglobin

    Blood samples were collected for the analysis of haematology parameter including: Haemoglobin.

    Measured: From screening up to end-of-trial (approximately 5.5 months)

  45. Change From Baseline in Haematology Parameter: Haematocrit

    Blood samples were collected for the analysis of haematology parameter including: Haematocrit.

    Measured: From screening up to end-of-trial (approximately 5.5 months)

  46. Change From Baseline in Haematology Parameter: Erythrocyte Mean Corpuscular Volume

    Blood samples were collected for the analysis of haematology parameter including: Erythrocyte mean corpuscular volume.

    Measured: From screening up to end-of-trial (approximately 5.5 months)

  47. Change From Baseline in Haematology Parameter: Erythrocyte Mean Corpuscular Haemoglobin

    Blood samples were collected for the analysis of haematology parameter including: Erythrocyte mean corpuscular haemoglobin.

    Measured: From screening up to end-of-trial (approximately 5.5 months)

  48. Change From Baseline in Haematology Parameter: Erythrocyte Mean Corpuscular Haemoglobin Concentration

    Blood samples were collected for the analysis of haematology parameter including: Erythrocyte mean corpuscular haemoglobin concentration.

    Measured: From screening up to end-of-trial (approximately 5.5 months)

  49. Change From Baseline in Haematology Parameters: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes and Neutrophils/Leukocytes

    Blood samples were collected for the analysis of haematology parameters including: Basophils/leukocytes, Eosinophils/leukocytes, Lymphocytes/leukocytes, Monocytes/leukocytes and Neutrophils/leukocytes.

    Measured: From screening up to end-of-trial (approximately 5.5 months)

  50. Proportion of Subjects With Markedly Abnormal Changes of Haematology Parameters: Leukocytes, Lymphocytes/Leukocytes

    The table represents the percentage of participants in each group with normal baseline values and markedly abnormal end-of-stimulation and end-of-trial values for leukocytes and lymphocytes/leukocytes.

    Measured: End-of-stimulation visit and end-of-trial visit

  51. Number of Immune-related Adverse Events

    Standardised Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQs).

    Measured: From screening up to end-of-trial (approximately 5.5 months)

  52. Frequency of Injection Site Reactions

    Assessed by the participant during the stimulation period. Participants assessed the injection site reactions (redness, pain, itching, swelling and bruising) three times daily: immediately after the injection, 30 minutes after the injection and 24 hours after the injection.

    Measured: End-of-stimulation (up to 20 stimulation days)

  53. Intensity of Injection Site Reactions

    Assessed by the participant during the stimulation period as mild, moderate or severe. Participants are tabulated according to the highest severity of their reported injection site reactions.

    Measured: End-of-stimulation (up to 20 stimulation days)

  54. Proportion of Subjects With Treatment-induced Anti-FSH Antibodies, Overall as Well as With Neutralizing Capacity

    Measured by presence of anti-FSH antibodies.

    Measured: Up to 28 days after end of the stimulation period

  55. Intensity of Immune-related Adverse Events

    The intensity of immune-related adverse event was classified using the following 3-point scale: mild = awareness of signs or symptoms, but no disruption of usual activity; moderate = event sufficient to affect usual activity (disturbing); or severe = inability to work or perform usual activities (unacceptable).

    Measured: From screening up to end-of-trial (approximately 5.5 months)

  56. Proportion of Subjects With Cycle Cancellations Due to an Adverse Event, Including Immune-related Adverse Events, or Due to Technical Malfunctions of the Administration Pen

    For each participant the reason for cycle cancellation will be recorded.

    Measured: Up to 20 stimulation days

  57. Proportion of Subjects With Late OHSS

    Late OHSS was defined as OHSS with onset >9 days after triggering of final follicular maturation. The proportion of participants with late OHSS, and late OHSS of moderate or severe grade are presented. All OHSS cases were graded as mild, moderate, or severe.

    Measured: After 9 days post triggering of final follicular maturation

  58. Proportion of Participants With Multi-fetal Gestation

    Defined as pregnancy with more than one fetus. Among participants with ongoing pregnancy, percentage of participants with twin pregnancies are presented.

    Measured: End-of-trial

  59. Proportion of Participants With Early Pregnancy Losses

    Grouped according to occurrence of biochemical pregnancy, spontaneous abortion, vanishing twin or ectopic pregnancy (with and without medical/surgical intervention).

    Frequency of early pregnancy losses are presented.

    Measured: End-of-trial

  60. Proportion of Participants With Technical Malfunctions of the Administration Pen

    Incidences of technical malfunctions of the administration pen were recorded.

    Measured: End-of-stimulation (up to 20 stimulation days)

Timeline

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

  1. First posted28 Sep 2017
  2. Study start1 Dec 2017
  3. Primary completion3 Jan 2020
  4. Study completion26 Jul 2020

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
1,011 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03296527
Sponsor's protocol ID
000145
Status last verified
Apr 2021
First submitted
14 Sep 2017
Last updated
24 Aug 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Qiao J, Zhang Y, Liang X, Ho T, Huang HY, Kim SH, Goethberg M, Mannaerts B, Arce JC. A randomised controlled trial to clinically validate follitropin delta in its individualised dosing regimen for ovarian stimulation in Asian IVF/ICSI patients. Hum Reprod. 2021 Aug 18;36(9):2452-2462. doi: 10.1093/humrep/deab155.

    PubMed 34179971

  • Yang R, Zhang Y, Liang X, Song X, Wei Z, Liu J, Yang Y, Tan J, Zhang Q, Sun Y, Wang W, Qian W, Jin L, Wang S, Xu Y, Yang J, Goethberg M, Mannaerts B, Wu W, Zheng Z, Qiao J. Comparative clinical outcome following individualized follitropin delta dosing in Chinese women undergoing ovarian stimulation for in vitro fertilization /intracytoplasmic sperm injection. Reprod Biol Endocrinol. 2022 Oct 4;20(1):147. doi: 10.1186/s12958-022-01016-y.

    PubMed 36195924

  • Fernandez-Sanchez M, Fatemi H, Garcia-Velasco JA, Heiser PW, Daftary GS, Mannaerts B. Incidence and severity of ovarian hyperstimulation syndrome (OHSS) in high responders after gonadotropin-releasing hormone (GnRH) agonist trigger in "freeze-all" approach. Gynecol Endocrinol. 2023 Dec;39(1):2205952. doi: 10.1080/09513590.2023.2205952.

    PubMed 37156263

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Follitropin alfa and Follitropin delta in people with Controlled Ovarian Simulation, run by Ferring Pharmaceuticals at 26 sites in 4 countries.

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 13 inclusion and 28 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 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in China, South Korea, Taiwan, Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

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 1 Jun 2021). 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?

Ongoing Pregnancy Rate (time frame: 10-11 weeks after transfer). 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 NCT03296527, which also lists 3 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 24 Aug 2023.

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