Comparison Between Two Ovulation Induction Therapies and LOD on Clinical Outcomes in CC-Resistant PCOS Women

Phase 3

Completed

• Conditions: PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
• Interventions: Procedure: laparoscopic ovarian drilling; Drug: Gonadotropin; Drug: Letrozole

• Registration Number: NCT06486870
• Lead Sponsor: Cairo University

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 higher prevalence of 17.8-19.9% based on Rotterdam diagnostic criteria. PCOS is diagnosed by the presence of at least two out of three criteria: oligo- and/or anovul...

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 with PCOS. Conducted at Kasr El Aini Maternity Hospital, Cairo University, gynecological and infertility clinics.
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Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-31
• Status Verified: 2024-06
• Study First Submitted: 2024-06-27
• Study First Submitted QC: 2024-06-27
• Last Update Submitted: 2024-06-27
• Study First Posted: 2024-07-05
• Last Update Posted: 2024-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 183

Inclusion Criteria

• 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)

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Exclusion Criteria

• 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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
unilateral laparoscopic ovarian drilling	laparoscopic ovarian drilling	Laparoscopic ovarian drilling will be done according to the following: Electrocautery using a mixed current in monopolar electrosurgical needle will be into introduced through the ovarian ipsilateral parts and applied up to 4 point cauterisation of the ovarian capsule, each for 4 second, at 40 W and for a diameter of 3mm and a depth of 4 mm in the antimesentric surface . (Amer et al 2003, Sawant S et al 2019) ,the procedure will be applied for one ovary . The patient under the study will be followed up to six months of continuous marital life after the procedure
gonadotropin	Gonadotropin	Human menopausal gonadotrophin (hMG) is given starting on cycle day three in a dose of 75 IU alternate days. The aim of treatment is to achieve mono-ovulation. Monitoring of treatment is achieved by serial transvaginal ultrasound scanning every other day starting from cycle day nine. Size and number of follicles is recorded in patients follow up sheets. The dose of hMG is reviewed around stimulation day 10 and if follicular development is unsatisfactory, the dose is increased to 75 IU daily .If a good response is not achieved day16 ; the cycle is cancelled. A new cycle is commenced with a higher starting dose of hMG (75 IU per day). When one follicle reached a size of \> =18 mm a single dose of 10,000 IU human chorionic gonadotrophin (hCG, Pregnyl, Epifasi, Choriomon) is given.
letrozole	Letrozole	: 5 mg LE oral tablets are administered on the fifth day of menses and then every day for 5 days. Treatment is repeated for up to six cycles

Primary Outcome Measures

Name	Time	Method
pregnancy rate	6 month	identified by serum β-HCG of \>50 IU/L and gestational sac seen on ultrasound.

Secondary Outcome Measures

Name	Time	Method
ovulation rate	6 months	The ovulation rate refers to the percentage of women who successfully ovulate after a particular treatment regimen during a specified time period.
multiple pregnancy rate	6 months	The multiple pregnancy rate refers to the percentage of pregnancies that result in the birth of more than one baby, such as twins, triplets, or higher-order multiples, following a particular fertility treatment.
miscarriage rate	6 months	The miscarriage rate refers to the percentage of pregnancies that end in miscarriage, defined as the spontaneous loss of a pregnancy before the fetus reaches viability (usually before 20 weeks of gestation).

Trial Locations

Locations (1)

faculty of medicine, Kasr el ainy hospital, Cairo university; 🇪🇬 Cairo, Egypt