Ovulation InductionPhase 2NCT00697255
A Phase 2 Trial to Evaluate if Corifollitropin Alfa (Org 36286), Followed by a Low Daily Dose of hCG or Recombinant FSH Can Induce Monofollicular Growth in Women With WHO Group II Anovulatory Infertility (P05693)
A Phase 2 study testing corifollitropin alfa, recombinant Follicle Stimulating Hormone (recFSH) and human Chorion Gonadotropin (hCG) in people with Ovulation Induction, run by Organon and Co.
Trial summary
The primary objective of this trial is to evaluate whether a corifollitropin alfa (Org 36286) regimen applying a single or repeated dose of corifollitropin alfa followed by a low daily dose of Human Chorion Gonadotropin (hCG) or recombinant Follicular Stimulating Hormone (recFSH) can induce monofollicular growth (one… Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Ovulation Induction
- What is being tested?
- corifollitropin alfa, recombinant Follicle Stimulating Hormone (recFSH) and human Chorion Gonadotropin (hCG)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2007to 15 May 2008
- Phase
- Phase 2
- 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
- Oligomenorrhea (average cycle length ≥35 days and <6 months)
- Amenorrhea (average cycle length ≥6 months)
- Body Mass Index ≥18 and ≤30 kg/m^2
- Normal serum FSH levels and normal estradiol levels at screening
- Progestagen induced withdrawal bleeding
- Age ≥18 years and ≤39 years at the time of signing informed consent
- Willing and able to sign informed consent
Who cannot join
- History of or current ovarian cysts or enlarged ovaries not related to polycystic ovarian syndrome (PCOS)
- History of or current tumors of the ovary, breast, uterus, pituitary or
- hypothalamus
- Less than 2 ovaries
- Undiagnosed vaginal bleeding
- Any ovarian and/or abdominal abnormality interfering with ultrasound
Show all 16Show fewer
- examination
- Malformations of the sexual organs incompatible with pregnancy
- Pregnancy or lactation
- Abnormal serum endocrinology levels based on screening sample
- Any clinically relevant abnormal laboratory value based on screening sample
- Alcohol or drug abuse within the 12 months preceding signing of informed consent
- Hypersensitivity to any of the substances in corifollitropin alfa
- Hypersensitivity to hCG/ Puregon® or any of its components
- Previous use of corifollitropin alfa
- Use of any investigational drug during 90 days before screening
About this study
Official title: A Phase II, Randomized, Controlled, Open-label, Feasibility Trial to Evaluate if a Single or Repeated Dose of Org 36286 (Corifollitropin Alfa) Followed by a Low Daily Dose of Either hCG or Recombinant FSH Can Induce Monofollicular Growth in Women With WHO Group II Anovulatory Infertility
The primary objective of this trial is to evaluate whether a corifollitropin alfa (Org 36286) regimen applying a single or repeated dose of corifollitropin alfa followed by a low daily dose of Human Chorion Gonadotropin (hCG) or recombinant Follicular Stimulating Hormone (recFSH) can induce monofollicular growth (one follicle ≥18 mm and no other follicle ≥15 mm at day of bolus injection of hCG) in women with WHO group II anovulatory infertility.
Read the detailed description
This trial will include two separate stages (Ia+Ib and II).
Stage Ia will be open-label and uncontrolled in a small cohort of women (n=5) to explore whether the intended dosing regimen of corifollitropin alfa followed by daily low dose recFSH provide an appropriate response in eligible participants meeting all inclusion and none of the exclusion criteria.
Stage Ib will be open-label and uncontrolled in a small cohort of women (n=5) to explore whether the intended dosing regimen of corifollitropin alfa followed by daily low dose hCG provide an appropriate response in eligible participants meeting all inclusion and none of the exclusion criteria.
Stage II is open-label and randomized (n=40) to evaluate whether the intended dosing regimen of corifollitropin alfa followed by low dose FSH (n=20) or hCG (n=20) provide an appropriate response in eligible participants meeting all inclusion and none of the exclusion criteria.
- Conditions
- Ovulation Induction
- Being tested
- corifollitropin alfa, recombinant Follicle Stimulating Hormone (recFSH), human Chorion Gonadotropin (hCG), hCG Bolus injection
- Keywords
- Pharmacological effects of drugs, Hormones, Hormone Substitutes and Hormone Antagonists, Pharmacological Actions, Monofollicular growth, Randomized, Open-label, Active-controlled
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
SC corifollitropin alfa on the 1st, 2nd or 3rd day after onset of a progestagen-induced withdrawal bleeding (Stage 1a: 15mcg, Stage Ib/II: 30 mcg).
recombinant Follicle Stimulating Hormone (recFSH)Biological
Also called Puregon®
Daily injections of SC recFSH (50 IU/75 IU) administered as soon as the largest follicle reaches a size ≥12 mm 4 days after a corifollitropin alfa injection on stimulation day 5, 9 or 13.
human Chorion Gonadotropin (hCG)Biological
Also called Pregnyl®
Daily injections of SC hCG (200 IU) administered as soon as the largest follicle reaches a size ≥12 mm 4 days after a corifollitropin alfa injection on stimulation day 5, 9 or 13.
hCG Bolus injectionBiological
Also called Pregnyl®
Bolus injection of SC hCG was administered to induce final oocyte maturation if at least one follicle is ≥18 mm and no more than two follicles ≥15 mm are observed.
| Study group | Role | What they receive |
|---|---|---|
| corifollitropin alfa + recFSH | Experimental | Eligible participants will receive a subcutaneous (SC) injection of corifollitropin alfa (Stage 1a: 15mcg, Stage Ib/II: 30 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth is insufficient, the participant will receive a second or third dose of corifollitropin alfa (Stage 1a: 15 mcg, Stage Ib/II: 20 mcg). As soon as the largest follicle reaches a size of ≥12 mm, the participant will start daily SC injections with FSH (Stage 1A: 50 IU, Stage II: 75 IU) the same day. A bolus injection of hCG (5000 IU) will be administered if at least one follicle is ≥18 mm and in total no more than two follicles ≥15 mm are observed. Receives: Drug: corifollitropin alfa; Biological: recombinant Follicle Stimulating Hormone (recFSH); Biological: hCG Bolus injection |
| corifollitropin alfa + hCG | Experimental | Eligible participants will receive a SC injection of corifollitropin alfa (Stage Ia:15 mcg, Stage Ib/II: 30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth is insufficient the participant will receive a second or third dose of corifollitropin alfa (Stage IA: 15 mcg, stage Ib/II: 20 mcg). As soon as the largest follicle reaches a size of ≥12 mm the participant will start daily SC injections with hCG (Stage Ib/II: 200 IU) the same day. A bolus injection of hCG (5000 IU) will be administered if at least one follicle is ≥18 mm and in total no more than two follicles ≥15 mm are observed. Receives: Drug: corifollitropin alfa; Biological: human Chorion Gonadotropin (hCG); Biological: hCG Bolus injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Monofollicular Response (Monofollicular Rate)
The monofollicular rate was defined as the number of participants with monofollicular response (one follicle ≥18 mm and no other follicle ≥15 mm on the day of the bolus injection of hCG) divided by the number of the treated participants.
Measured: At day of bolus injection of hCG (up to 20 days)
Secondary outcomes (5)
Percentage of Participants With Ovulation (Ovulation Rate)
Ovulation rate was defined as the number of participants with confirmed ovulation (≥15 nmol/l serum progesterone eight days after the bolus injection of hCG) divided by the number of treated participants. Ovulation was also considered confirmed for participants who became pregnant, had an ectopic pregnancy or had a miscarriage.
Measured: 8 days after bolus injection of hCG (up to 28 days)
Percentage of Participants With Monofollicular Ovulation (Monofollicular Ovulation Rate)
Monofollicular ovulation rate was defined as the number of participants with monofollicular response (one follicle ≥18 mm and no other follicle ≥15 mm on the day of the bolus injection of hCG) and confirmed ovulation (≥15 nmol/l serum progesterone eight days after the bolus injection of hCG) divided by the number of treated participants. Ovulation was also considered confirmed for participants who became pregnant, had an ectopic pregnancy or had a miscarriage.
Measured: 8 days after bolus injection of hCG (up to 28 days)
Percentage of Participants Who Cancelled Treatment (Cancellation Rate)
Treatment was considered cancelled if no bolus injection of hCG was administrated. Reasons of treatment failure included Adverse Event (AE)/ Serious Adverse Event (SAE), insufficient ovarian response on stimulation day 13 (no follicle ≥12 mm), insufficient ovarian response after 7 days of hCG/recFSH treatment (no follicle ≥18 mm), and multifollicular growth (≥3 follicles ≥15 mm).
Measured: Up to 3 weeks after bolus injection of hCG (up to 41 days)
Number of Participants With Pregnancy
A pregnancy test (serum or urinary hCG) was performed two to three weeks after bolus injection of hCG. In case of a positive pregnancy test vaginal and/or abdominal ultrasound scan was performed to confirm the pregnancy at 5 to 6 weeks after bolus injection of hCG and ≥10 weeks after bolus injection of hCG to confirm ongoing pregnancy.
Measured: At least 10 weeks after bolus injection of hCG (up to 13 weeks)
Number of Participants With AEs of 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: During In-Treatment Period (up to 14 weeks after first corifollitropin injection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2008 (estimated)
- Study start15 May 2007
- Primary completion3 Apr 2008
- Study completion15 May 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ovulation InductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00697255
- Sponsor's protocol ID
- P05693
- Other IDs
- 2006-000705-30, 107010, MK-8962-002
- Status last verified
- Feb 2022
- First submitted
- 11 Jun 2008
- Last updated
- 17 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Controlled, Open-label, Feasibility Trial to Evaluate if a Single or Repeated Dose of Org 36286 (Corifollitropin Alfa) Followed by a Low Daily Dose of Either hCG or Recombinant FSH Can Induce Monofollicular Growth in Women With WHO Group II Anovulatory Infertility
- ClinicalTrials.gov ID
- NCT00697255
- Acronym / sponsor ID
- P05693
- Conditions
- Ovulation Induction
- Keywords
- Pharmacological effects of drugs, Hormones, Hormone Substitutes and Hormone Antagonists, Pharmacological Actions, Monofollicular growth, Randomized, Open-label, Active-controlled
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 15 May 2007 (actual)
- Primary completion
- 3 Apr 2008 (actual)
- Study completion
- 15 May 2008 (actual)
- First posted
- 13 Jun 2008 (estimated)
- Results
- Posted 9 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this trial is to evaluate whether a corifollitropin alfa (Org 36286) regimen applying a single or repeated dose of corifollitropin alfa followed by a low daily dose of Human Chorion Gonadotropin (hCG) or recombinant Follicular Stimulating Hormone (recFSH) can induce monofollicular growth (one follicle ≥18 mm and no other follicle ≥15 mm at day of bolus injection of hCG) in women with WHO group II anovulatory infertility.
Detailed description
This trial will include two separate stages (Ia+Ib and II).
Stage Ia will be open-label and uncontrolled in a small cohort of women (n=5) to explore whether the intended dosing regimen of corifollitropin alfa followed by daily low dose recFSH provide an appropriate response in eligible participants meeting all inclusion and none of the exclusion criteria.
Stage Ib will be open-label and uncontrolled in a small cohort of women (n=5) to explore whether the intended dosing regimen of corifollitropin alfa followed by daily low dose hCG provide an appropriate response in eligible participants meeting all inclusion and none of the exclusion criteria.
Stage II is open-label and randomized (n=40) to evaluate whether the intended dosing regimen of corifollitropin alfa followed by low dose FSH (n=20) or hCG (n=20) provide an appropriate response in eligible participants meeting all inclusion and none of the exclusion criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| corifollitropin alfa + recFSH | Experimental | Drug: corifollitropin alfa, Biological: recombinant Follicle Stimulating Hormone (recFSH), Biological: hCG Bolus injectionEligible participants will receive a subcutaneous (SC) injection of corifollitropin alfa (Stage 1a: 15mcg, Stage Ib/II: 30 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth is insufficient, the participant will receive a second or third dose of corifollitropin alfa (Stage 1a: 15 mcg, Stage Ib/II: 20 mcg). As soon as the largest follicle reaches a size of ≥12 mm, the participant will start daily SC injections with FSH (Stage 1A: 50 IU, Stage II: 75 IU) the same day. A bolus injection of hCG (5000 IU) will be administered if at least one follicle is ≥18 mm and in total no more than two follicles ≥15 mm are observed. |
| corifollitropin alfa + hCG | Experimental | Drug: corifollitropin alfa, Biological: human Chorion Gonadotropin (hCG), Biological: hCG Bolus injectionEligible participants will receive a SC injection of corifollitropin alfa (Stage Ia:15 mcg, Stage Ib/II: 30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth is insufficient the participant will receive a second or third dose of corifollitropin alfa (Stage IA: 15 mcg, stage Ib/II: 20 mcg). As soon as the largest follicle reaches a size of ≥12 mm the participant will start daily SC injections with hCG (Stage Ib/II: 200 IU) the same day. A bolus injection of hCG (5000 IU) will be administered if at least one follicle is ≥18 mm and in total no more than two follicles ≥15 mm are observed. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Oligomenorrhea (average cycle length ≥35 days and <6 months)
- Amenorrhea (average cycle length ≥6 months)
- Body Mass Index ≥18 and ≤30 kg/m^2
- Normal serum FSH levels and normal estradiol levels at screening
- Progestagen induced withdrawal bleeding
Key exclusion criteria (16 listed)
- History of or current ovarian cysts or enlarged ovaries not related to polycystic ovarian syndrome (PCOS)
- History of or current tumors of the ovary, breast, uterus, pituitary or
- hypothalamus
- Less than 2 ovaries
- Undiagnosed vaginal bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| corifollitropin alfaAlso: Org 36286, SCH 900962, MK-8962SC corifollitropin alfa on the 1st, 2nd or 3rd day after onset of a progestagen-induced withdrawal bleeding (Stage 1a: 15mcg, Stage Ib/II: 30 mcg). | Drug | corifollitropin alfa + hCG, corifollitropin alfa + recFSH |
| recombinant Follicle Stimulating Hormone (recFSH)Also: Puregon®Daily injections of SC recFSH (50 IU/75 IU) administered as soon as the largest follicle reaches a size ≥12 mm 4 days after a corifollitropin alfa injection on stimulation day 5, 9 or 13. | Biological | corifollitropin alfa + recFSH |
| human Chorion Gonadotropin (hCG)Also: Pregnyl®Daily injections of SC hCG (200 IU) administered as soon as the largest follicle reaches a size ≥12 mm 4 days after a corifollitropin alfa injection on stimulation day 5, 9 or 13. | Biological | corifollitropin alfa + hCG |
| hCG Bolus injectionAlso: Pregnyl®Bolus injection of SC hCG was administered to induce final oocyte maturation if at least one follicle is ≥18 mm and no more than two follicles ≥15 mm are observed. | Biological | corifollitropin alfa + hCG, corifollitropin alfa + recFSH |
Primary outcome
Percentage of Participants With Monofollicular Response (Monofollicular Rate)
Time frame: At day of bolus injection of hCG (up to 20 days)
The monofollicular rate was defined as the number of participants with monofollicular response (one follicle ≥18 mm and no other follicle ≥15 mm on the day of the bolus injection of hCG) divided by the number of the treated participants.
5 secondary outcomes
Percentage of Participants With Ovulation (Ovulation Rate)
Time frame: 8 days after bolus injection of hCG (up to 28 days)
Percentage of Participants With Monofollicular Ovulation (Monofollicular Ovulation Rate)
Time frame: 8 days after bolus injection of hCG (up to 28 days)
Percentage of Participants Who Cancelled Treatment (Cancellation Rate)
Time frame: Up to 3 weeks after bolus injection of hCG (up to 41 days)
Number of Participants With Pregnancy
Time frame: At least 10 weeks after bolus injection of hCG (up to 13 weeks)
Number of Participants With AEs of Ovarian Hyperstimulation Syndrome (OHSS)
Time frame: During In-Treatment Period (up to 14 weeks after first corifollitropin injection)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing corifollitropin alfa, recombinant Follicle Stimulating Hormone (recFSH) and human Chorion Gonadotropin (hCG) in people with Ovulation Induction, 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 7 inclusion and 16 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: stopped early, as of the sponsor's last update on 17 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 9 Jun 2014). 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 Monofollicular Response (Monofollicular Rate) (time frame: At day of bolus injection of hCG (up to 20 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jun 2024.