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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 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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Who is running the clinical trial?

Clinique OvoLead Sponsor
32 Previous Clinical Trials
41,406 Total Patients Enrolled
1 Trials studying Polycystic Ovary Syndrome
Joanne Benoit, MDPrincipal InvestigatorClinique Ovo
~16 spots leftby Jan 2025
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