Status:
COMPLETED
Comparison Between Two Ovulation Induction Therapies and LOD on Clinical Outcomes in CC-Resistant PCOS Women
Lead Sponsor:
Cairo University
Conditions:
PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
Eligibility:
FEMALE
20-35 years
Phase:
PHASE3
Brief Summary
Polycystic ovary syndrome (PCOS) is a prevalent endocrine disorder affecting 4-8% of reproductive-aged women and is a leading cause of infertility due to oligo-anovulation (1). Studies suggest a highe...
Detailed Description
\### Materials and Methods \*\*Design:\*\* A randomized clinical study to evaluate and compare the effects of gonadotropins, Letrozole, and unilateral laparoscopic ovarian drilling in infertile women...
Eligibility Criteria
Inclusion
- Age 20 to 35 years
- Infertile woman diagnosed to have PCO according to Rotterdam criteria as ovulatory distrbance, hyperandrogenism and presence of more than 12 follicles, 2- 9 mm in diameter in each other by ultrasound examination
- Resistance to clomiphene citrate i.e failed to respond to clomiphene citrate dose up to 150 mg per day for at least 3 cycles
- BMI from18-30
- High LH/FSH ratio≥1.5 , LH level ≥10IU/l)
Exclusion
- Extremes of age less than 20 years old or more than 35 years old
- Hormonal therapy and oral contraception for the past 3cycle
- Other causes of infertility including tubal , uterine and male causes .
- Pre-existing endocrine disease including thyroid disorder, cushing's syndrome and congenital adrenal hyperplasia
- Any previous version surgery
- Obese patients with BMI \>35
- Low ovarian reserve by AMH serum level measurement (AMH \< .5-1.1 ng/ml).
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2024
Estimated Enrollment :
183 Patients enrolled
Trial Details
Trial ID
NCT06486870
Start Date
January 1 2020
End Date
January 31 2024
Last Update
July 5 2024
Active Locations (1)
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1
faculty of medicine, Kasr el ainy hospital, Cairo university
Cairo, Egypt, 11562