Infertility Clinical Trial
Official title:
Extended Clomiphene Citrate Regimen Versus Laparoscopic Ovarian Drilling for Ovulation Induction in Clomiphene Citrate-resistant Women With Polycystic Ovary Syndrome
Verified date | August 2016 |
Source | Benha University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Egypt: Ministry of Higher Education |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 160 |
Est. completion date | July 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 35 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Egypt | Benha Faculty of Medicine | Benha | El Qaluobia |
Lead Sponsor | Collaborator |
---|---|
Benha University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the ovulation rate | serum progesterone was = 5 ng/mL. | midluteal (day 21of the cycle) | Yes |
Secondary | the endometrial thickness | Sonographic of endometrial thickness | the day of the hCG injection | Yes |
Secondary | the rates of clinical pregnancy | Serum ß-hCG is determined Sonographic evidence of an intrauterine gestational sac at 6 weeks gestation was considered an evident of a clinical pregnancy. | 2 weeks after HCG injection | Yes |
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