Extended Clomiphene Citrate Regimen in Women With Polycystic Ovary Syndrome

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

One hundred and thirty six anovulatory women with CC-resistant PCOS were scheduled randomly into two equal groups. Group A (n=68); received CC (100 mg/day from cycle day 3 for 10 days) for up to six cycles. Group B (n=68) underwent LOD and followed up for 6 months. The primary outcome was the ovulation rate in each group; secondary outcomes were midcycle endometrial thickness and serum estradiol, midluteal serum progesterone, and the rates of clinical pregnancy and abortion.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Benha University
• Treatments: Citric Acid; Clomiphene; Enclomiphene; Zuclomiphene

Criteria

Inclusion Criteria:

• Age: between 18-35 years

• Period of infertility > 2 years

• Serum level of FSH <10 U/L in the early follicular phase

• All women were CC-resistant PCOS, as they failed to ovulate with a dose of CC of 150 mg/day for 5 days per cycle for at least three consecutive cycles

• All women had patent Fallopian tubes proved by hysterosalpingography or laparoscopy and their partners satisfied the normal parameters of semen analysis according to the modified WHO criteria

Exclusion Criteria:

• Infertility due to causes other than CC- resistant PCOS or due to combined factors

• Body mass index (BMI) ≥35 Kg/m²

• The use of metformin, gonadotropins, hormonal contraception or diet regimen within the last 6 months

• Women with congenital adrenal hyperplasia, hyperprolactinaemia or abnormal thyroid function

• Hypersensitivity or contraindications to Letrozole or clomiphene treatment

• Previous LOD