A Study to Explore Correlation Between Symptoms and Signs of Polycystic Ovarian Syndrome (PCOS) a… (NCT02607293) | Clinical Trial Compass
CompletedNot Applicable
A Study to Explore Correlation Between Symptoms and Signs of Polycystic Ovarian Syndrome (PCOS) and Risk of Over-response to Ovarian Stimulation
Germany1,064 participantsStarted 2015-12-31
Plain-language summary
This is a Phase IV, prospective, observational, single arm, multicenter trial to identify the population at high risk of overstimulation associated with signs and symptoms of PCOS and examines the utility of 12.5 international units (IU) increment of Gonal-f® new pen for individualized controlled ovarian stimulation (iCOS).
Who can participate
Age range
20 Years – 35 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:
* Female subjects aged 20 to 35 years (including both)
* Subjects undergoing ART treatment with long GnRH-a protocol or GnRH-ant protocol + Gn + human chorionic gonadotropin (hCG)
* Subject from whom a written informed consent has been obtained with the understanding that the subject may withdraw consent at any time without prejudice to future medical care
Exclusion Criteria:
* Subjects undergoing ART treatment with mild stimulation protocol
* Concomitant use of Gonal-f® with clomiphene citrate
* With an In vitro fertilisation (IVF)/ Intracytoplasmic sperm injection (ICSI) history of greater than or equal to (\>=) 3 times
* Known history of poor ovarian response in a previous COS cycle for IVF/ICSI, defined as less than 4 oocytes retrieved or history of previous cycle cancellation prior to oocyte retrieval due to poor response or poor ovarian reserve, such as Antral follicle count (AFC) less than (\<) 5 to 7
* Presence of confirmed or suspected endometriosis Grade III - IV
* Presence of unilateral or bilateral hydrosalpinx
* Using other Gn during stimulation period (such as urinary FSH/human menopausal Gn, except for recombinant luteinizing hormone (r-LH))
* Known history of recurrent miscarriage
* Any contradiction to Gn/GnRH analogues
* Any major systemic disease that as per Investigator's discretion precludes subject for participation in the study
* According to the judgment of the Investigator, any medical condition or any concomitant
* surgery/ med…
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 subjects with polycystic ovary
Timeframe: Baseline
2
Serum Testosterone levels
Timeframe: Baseline
3
Number of subjects with history of menstrual disorders
Timeframe: Baseline
4
Number of subjects with hirsutism
Timeframe: Baseline
5
Number of oocytes retrieved
Timeframe: Baseline up to 2-7 days until end of stimulation cycle (approximately 28 days)