Polycystic Ovary Syndrome, Polycystic Ovary Syndrome (PCOS) Women
Conditions
Brief summary
Extended letrozole protocol versus letrozole plus Inositol for Induction of ovulation in letrozole resistant PCOS Women
Interventions
DRUGELP (Extended Letrozole Protocol)
? ELP (Extended Letrozole Protocol) Participants allocated to this arm will receive letrozole 5 mg orally once daily, starting on day 2 of the menstrual cycle and continued for 7 consecutive days. Follicular development will be monitored using transvaginal ultrasonography every 48 hours starting after the last dose of letrozole until confirmation of ovulation. When at least one dominant follicle reaches a mean diameter of 18-20 mm, human chorionic gonadotropin (hCG) will be administered to trigger ovulation. Timed intercourse will be advised accordingly. Endometrial thickness will be measured on the day of ovulation trigger. This protocol may be repeated for up to 3 consecutive cycles in case ovulation is not achieved.
DRUGLIP (Letrozole + Inositol Protocol)
? LIP (Letrozole + Inositol Protocol) Participants allocated to this arm will receive myo-inositol 2 g orally twice daily for a duration of 3 months prior to ovulation induction. In the subsequent cycle, letrozole 5 mg orally once daily will be administered starting on day 2 of the menstrual cycle for 5 consecutive days. Follicular monitoring will be performed using transvaginal ultrasonography every 48 hours after the last dose of letrozole until ovulation is confirmed. Ovulation will be triggered using hCG injection when at least one follicle reaches 18-20 mm in diameter, followed by timed intercourse. Compliance with inositol intake and any adverse effects will be documented throughout the study period.
Sponsors
Eman Basuni Ebrahim Mowad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Women diagnosed with polycystic ovary syndrome (PCOS) according to the Rotterdam criteria. * Letrozole-resistant PCOS patients who failed to ovulate after receiving letrozole 5 mg daily for 5 days for three consecutive cycles. * Age 18 to 35 years. * Body mass index (BMI) ≤ 30 kg/m². * Normal uterine cavity and patent fallopian tubes confirmed by hysterosalpingography (HSG) and/or laparoscopy. * Partner with normal semen analysis. * Willing and able to provide informed consent.
Exclusion criteria
* Thyroid dysfunction. * Hyperprolactinemia. * Diabetes mellitus. * Congenital adrenal hyperplasia. * Adrenal causes of hyperandrogenism. * Use of insulin-sensitizing medications (e.g., metformin) during the study period. * Chronic liver disease. * Chronic kidney disease. * Contraindications to pregnancy. * Contraindications or hypersensitivity to inositol or letrozole.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ovulation Rate | At the end of Cycle 1 (each treatment cycle is 28 days). | The proportion of participants achieving ovulation after treatment with either an extended letrozole protocol (5 mg daily for 7 days) or letrozole plus inositol protocol in letrozole-resistant PCOS women. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Spontaneous Ovulation Rate | Up to 3 months after treatment initiation. | The proportion of participants who achieve spontaneous ovulation during the study period. |
| Clinical Pregnancy Rate | Up to 12 weeks after treatment initiation. | The proportion of participants with clinical pregnancy confirmed by transvaginal ultrasonographic visualization of a gestational sac. |
Countries
Egypt
Outcome results
None listed