TerminatedNot Applicable

Effect of Hyperandrogenism on IVF Outcomes in PCOS Patients

Stopped: Low recruitment rate

Canada32 participantsStarted 2022-01-21

Plain-language summary

Ovulatory dysfunction affects 18 to 25% of infertile women, the most common identifiable condition is polycystic ovarian syndrome (PCOS). The most frequent symptoms of PCOS are oligo-anovulation, hyperandrogenism and polycystic ovary appearance. Hyperandrogenism is the main contributor that affects oocyte and embryo quality and decreases the success rates in PCOS patients undergoing IVF treatments. The aim of this study is to determine the effect of hyperandrogenism as an independent factor on IVF success rates and oocyte/embryo quality in PCOS patients undergoing IVF.

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: * Women between ages of 18 - 39 inclusively * ≥15 oocytes collected on the day of oocyte retrieval and/or anti-mullerian hormone (AMH) ≥ 4.0 ng/ml in the participant's medical chart in the last 24 months Exclusion Criteria: * Male factor necessitating testicular sperm aspiration (TESA), testicular sperm extraction (TESE) or micro-TESE * Fertility preservation * Recurrent pregnancy losses (RPL) (defined as 2 or more failed clinical pregnancies as documented by ultrasonography or histopathologic examination,or 3 or more failed pregnancies before 14 weeks of gestation) * Oocyte donation * Medical diagnosis of non classic congenital adrenal hyperplasia diagnosed based on 17 hydroxyprogesterone level

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

Evaluate the effect of hyperandrogenism on frozen embryo transfer

Timeframe: 10 days after frozen embryo transfer

Trial details

NCT IDNCT05555680

SponsorClinique Ovo

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-01-29

View on ClinicalTrials.gov More PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries trials