Recombinant Follicle-stimulating Hormone in Treatment for Infertility (NCT05266924) | Clinical Trial Compass
UnknownPhase 3
Recombinant Follicle-stimulating Hormone in Treatment for Infertility
India250 participantsStarted 2022-07-23
Plain-language summary
This is a randomized multi-centre, assessor-blind, parallel-group study to be conducted in 250 women in the age group of 20 to 39 years (both inclusive), who are indicated to undergo COS as part of assisted reproductive technology (ART). The participant will receive r-hFSH, fixed-dose for 5 days, and day 6 onwards the dose may be adjusted for a single cycle of COS followed by ART procedures, and post-ART follow-up for ongoing pregnancy.
The primary and secondary outcomes will be captured on days as per protocol. Adverse events will be noted for safety evaluation.
Who can participate
Age range
20 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
. FSH level \<10 IU/L and Estradiol levl \<80 pg/mL at day 2 or 3
. Anti-mullerian hormone (AMH) level between 1 to 3.5 ng/mL during the menstrual cycle
Exclusion criteria
. Any agent(s) known to affect ovulation (e.g., neuroleptics);
. Drugs known or suspected to be teratogenic in nature.
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
1
Number of oocytes retrieved
Timeframe: Oocyte pick up - up to ~ 34 to 36 hours after human chorionic gonadotropin (hCG) administration