TerminatedPhase 2

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)

8 participantsStarted 2007-05-15

Plain-language 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 follicle ≥18 mm and no other follicle ≥15 mm at day of bolus injection of hCG) in women with WHO group II anovulatory infertility.

Who can participate

Age range

18 Years – 39 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Participants With Monofollicular Response (Monofollicular Rate)

Timeframe: At day of bolus injection of hCG (up to 20 days)

Trial details

NCT IDNCT00697255

SponsorOrganon and Co

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-04-03

Results submitted2014-03-28

View on ClinicalTrials.gov More Ovulation Induction trials