Fertility-female
Conditions
Interventions
Extended Letrozole Protocol
Inositol Letrozole Combination
Sponsors
None
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Women aged between 18-35 years and diagnosed with PCOS who were seeking conception and presented at the outpatient’s infertility clinic of our department were eligible for initial evaluation. Eligibility criteria included a confirmed diagnosis of PCOS according to Rotterdam criteria [16], ovulation resistance to letrozole (no dominant follicles [>17mm] on mid cycle transvaginal ultrasound after a maximum letrozole dosing of 7.5 mg /day for 5 cycle days starting from cycle day 2) [17], a Body Mass Index (BMI) less than or equal 30 kg/m2, and a normal Hysterosalpingography (HSG) and/or diagnostic laparoscopy.
Exclusion criteria
Exclusion criteria: Reasons for exclusion include women with endocrine disorders (e.g., active thyroid disease, adult-onset adrenal hyperplasia, diabetes, hyperprolactinemia, or adrenal-related hyperandrogenism), those concurrently using insulin-sensitizing medications like metformin, individuals with contraindications to pregnancy, and those with conditions that preclude inositol use, such as chronic liver or kidney disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study’s primary outcome was ovulation rate measured via TVUS every two days after the last letrozole dose to track follicular development and endometrial thickness until ovulation was confirmed. Confirmed ovulation was deemed when one follicle reached 18–20 mm in diameter. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes included clinical pregnancy rate (detection of an intrauterine gestational sac by a TVUS), endometrial thickness (measured on mid-cycle using TVUS), and the incidence of Ovarian Hyperstimulation Syndrome (OHSS) as an adverse event. | — |
Countries
Egypt
Contacts
Public ContactAhmed Soliman
Faculty of Medicine Mansoura University
Outcome results
None listed