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PCOS patients with no clinical or biochemical hyperandrogenism for Polycystic Ovary Syndrome (HIP Trial)

N/A

Recruiting

Led By Joanne Benoit, MD

Research Sponsored by Clinique Ovo

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 days after frozen embryo transfer

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Polycystic Ovary Syndrome

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 days after frozen embryo transfer

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 days after frozen embryo transfer

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 days after frozen embryo transfer for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Evaluate the effect of hyperandrogenism on frozen embryo transfer

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: PCOS patients with no clinical or biochemical hyperandrogenismExperimental Treatment1 Intervention

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

Group II: PCOS patients with clinical or biochemical hyperandrogenismExperimental Treatment1 Intervention

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.

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