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Trial Title:
Effect of Hyperandrogenism on IVF Outcomes in PCOS Patients
NCT ID:
NCT05555680
Condition:
PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
Conditions: Official terms:
Polycystic Ovary Syndrome
Hyperandrogenism
Conditions: Keywords:
Hyperandrogenism
Fertility issues
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Ferriman-Gallwey Score
Description:
The Ferriman-Gallwey score is used to evaluate hirsutism. The examiner scores the
subjects on a scale of 0-4 for terminal hair growth on eleven different body areas
according to the Ferriman-Gallwey scoring system. A Ferriman-Gallwey score of 8 or more
was considered diagnostic of hirsutism
Arm group label:
PCOS patients with clinical or biochemical hyperandrogenism
Arm group label:
PCOS patients with no clinical or biochemical hyperandrogenism
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.
Detailed description:
Despite that PCOS patients obtain a higher yield of oocytes retrieved in IVF treatments,
they often have lower fertilization, cleavage and implantation rates and a higher rate of
miscarriage, which can be attributed to a poor quality of retrieved oocytes and the
resulting embryos. Multiple studies compared IVF outcomes in PCOS patients to control
groups and found that PCOS might negatively affect oocyte maturation rate, fertilization
rate in conventional IVF and miscarriage rate. Hence, it seems that PCOS might be
associated with poor outcomes in IVF cycles when compared to non-PCOS patients.
Criteria for eligibility:
Study pop:
PCOS patients undergoing the first embryo transfer following the first IVF treatment
during the study period (or up to two embryo transfers)
Sampling method:
Probability Sample
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
39 Years
Locations:
Facility:
Name:
Clinique Ovo
Address:
City:
Montreal
Zip:
H4P 2S4
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Marya Far, MSc
Phone:
5147982000
Phone ext:
761
Email:
m.far@cliniqueovo.com
Start date:
January 21, 2022
Completion date:
December 30, 2025
Lead sponsor:
Agency:
Clinique Ovo
Agency class:
Industry
Source:
Clinique Ovo
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05555680
