Clinical trial · Observational
Effect of Hyperandrogenism on IVF Outcomes in PCOS Patients
Effect of Hyperandrogenism on IVF Success Rates in PCOS Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low recruitment rate
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ferriman-Gallwey Score | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- PCOS patients with clinical or biochemical hyperandrogenism
- description
- Clinical hyperandrogenism consists of patients with one of the following conditions: Acne, Hirsutism (using modified Ferriman-Gallwey (FG) score) or Androgenic alopecia Biochemical hyperandrogenism consists of elevated serum level of at least one of the following hormones: Total testosterone, free testosterone, DHEAS, androstenedione using the cut-offs adopted by the laboratory.
- interventionNames
- Other: Ferriman-Gallwey Score
- label
- PCOS patients with no clinical or biochemical hyperandrogenism
- description
- In this cohort, women have not be affected by either clinical of biochemical hyperandrogenism. The PCOS diagnosis will be based on oligo-anovulation and on polycystic ovaries during an ultrasound
- interventionNames
- Other: Ferriman-Gallwey Score
Primary outcomes (1)
- measure
- Evaluate the effect of hyperandrogenism on frozen embryo transfer
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 39 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available