Comparison Between Two Ovulation Induction Therapies and LOD on Clinical Outcomes in CC-Resistant PCOS Women
NCT Number: NCT06486870
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
Interventions: DRUG: Gonadotropin|DRUG: Letrozole|PROCEDURE: laparoscopic ovarian drilling
Sponsor: Cairo University
Sex: FEMALE
Age: ADULT
Enrollment: 183
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2020-01-01
Completion Date: 2024-01-31
Locations: faculty of medicine, Kasr el ainy hospital, Cairo university, Cairo, 11562, Egypt

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 anovulation, hyperandrogenism, and polycystic ovaries, with other etiologies excluded (2). Clomiphene citrate (CC), a selective estrogen receptor modulator, has been the first-line treatment for inducing ovulation in anovulatory women with PCOS for decades. Approximately 80% of women resume ovulation with CC, but only 35-40% achieve pregnancy. About 15-40% of women are resistant to CC, defined as failure to ovulate after receiving a maximum dosage of 150 mg per day for 5 days starting on the third day of the menstrual cycle. For CC-resistant women, metformin, an insulin sensitizer, has been explored but shows limited effectiveness except in combination with CC. Gonadotropins are the standard treatment for CC-resistant PCOS but come with risks of multiple pregnancies and ovarian hyperstimulation syndrome (OHSS) (3). Letrozole, an aromatase inhibitor, is another treatment option that prevents the conversion of androgens to estrogen, thereby increasing gonadotropin-releasing hormone (GnRH) secretion and promoting ovulation. Letrozole has shown superior ovulation and live birth rates compared to CC and is now recommended as the first-line treatment for anovulation in women with PCOS. It has comparable rates of OHSS and miscarriage to CC, but fewer relevant studies have compared it directly to laparoscopic ovarian drilling (LOD) (4). LOD is an alternative to gonadotropins for inducing ovulation in CC-resistant PCOS. It involves surgical intervention, which can be either unilateral or bilateral, and is effective without the risks of multiple pregnancies or OHSS. LOD also increases ovarian responsiveness to CC. Despite minimal morbidity, LOD can lead to tubo-ovarian adhesions and premature ovarian failure, although these risks are reduced by careful technique (5).

Primary Outcome Measures: pregnancy rate, identified by serum β-HCG of \>50 IU/L and gestational sac seen on ultrasound., 6 month
Secondary Outcome Measures: ovulation rate, The ovulation rate refers to the percentage of women who successfully ovulate after a particular treatment regimen during a specified time period., 6 months|multiple pregnancy rate, 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., 6 months|miscarriage rate, 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)., 6 months