Effect of Adding Isoflavonoids to Clomiphene Citrate for Ovulation Induction in Women With Polycystic Ovary Syndrome
Overview
- Phase
- Not Applicable
- Intervention
- Rosafem (FEMININE FORMULA)
- Conditions
- Ovulation Induction
- Sponsor
- FAlbasri
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Clinical pregnancy rate
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
This prospective, randomized clinical trial double blinded study, has been carried on 160 infertile patients seeking pregnancy in Gynecology and Obstetrics Department, Zagazig University Hospitals during the period from January 2019 to November 2019, the participants' randomizations were done and patients divided into two groups; group I: included 80 women receiving Clomiphene citrate (CC) plus Isoflavonoids. Group 2: included 80 women receiving Clomiphene citrate only
Detailed Description
Phytoestrogens continue to be of increasing interest because of their possible influence on the physiology of the reproductive tract. The aim of Prospective randomized clinical trial study is to evaluate effect of adding isoflavonoids to clomiphene citrate during ovulation induction in women with PCOS on the endometrial thickness which has an impact on pregnancy rate. This study included 160 infertile women seeking pregnancy and they were divided into two groups. Clomiphene is given orally at dose, one tablet twice per day (tablet 50 mg), from day 3 to day 7 for all patients (group I and group II),while phytoestrogens are given at dose, two tablets two times per day (tablet 800mg), from day 3 to day 12 only for group I, followed by HCG injection on attaining mature follicle(s) by trans-vaginal US scan with diameter ≥ 18 mm.
Investigators
FAlbasri
Resident of Obstetrics and Gynecology, Alkhoms Hospital, Misurata University, Libya
Zagazig University
Eligibility Criteria
Inclusion Criteria
- •Patient aged 18- 35 years old with primary or secondary infertility
Exclusion Criteria
- •Patient aged 18- 35 years old with primary or secondary infertility
- •Patient whose husband has a male factor of infertility.
- •Hepatic, renal, diabetic, thyroid or cardiovascular disorders.
- •Organic pelvic disease (uterine fibroids or ovarian cysts).
- •Abnormality detected by HSG as blocked tubes
Arms & Interventions
The 1st group
included eighty (80) women receiving Clomiphene citrate (CC) in the form of (Clomid 50 mg tablet, Sanofi Aventis, France) at dose (100 mg/day in two divided doses, starting from day 3 to day 7 of the cycle), plus Phytoestrogens (Isoflavonoids) in the form of (RosaFem 800 mg tablet, DeluxLab, Egypt) at dose (1600 mg/day in two divided doses (each dose one tablet), starting from day 3 to day 12 of the cycle
Intervention: Rosafem (FEMININE FORMULA)
The 2nd group
included eighty (80) women receiving Clomiphene citrate only, at dose (100 mg/day, starting from day 3 to day 7 of the cycle).
Intervention: Rosafem (FEMININE FORMULA)
Outcomes
Primary Outcomes
Clinical pregnancy rate
Time Frame: up to 24 weeks
defined as the presence of gestational sac containing fetal hearts on ultrasound scan
Secondary Outcomes
- Endometrial thickness,(up to 24 weeks)
- ovulation rate(up to 24 weeks)