Effect of Adding Isoflavonoids to Clomiphene Citrate for Ovulation Induction in Women With Polycystic Ovary Syndrome

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome; Ovulation Induction
• Interventions: Drug: Rosafem (FEMININE FORMULA)

• Registration Number: NCT04610957
• Lead Sponsor: FAlbasri

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.

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2019-01-01
• Study Completion: 2019-04-10
• Status Verified: 2020-10
• Study First Submitted: 2020-10-01
• Study First Submitted QC: 2020-10-26
• Last Update Submitted: 2020-10-26
• Study First Posted: 2020-11-02
• Last Update Posted: 2020-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The 1st group	Rosafem (FEMININE FORMULA)	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
The 2nd group	Rosafem (FEMININE FORMULA)	included eighty (80) women receiving Clomiphene citrate only, at dose (100 mg/day, starting from day 3 to day 7 of the cycle).

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	up to 24 weeks	defined as the presence of gestational sac containing fetal hearts on ultrasound scan

Secondary Outcome Measures

Name	Time	Method
Endometrial thickness,	up to 24 weeks	endometrial thickness is used to monitor infertility treatment
ovulation rate	up to 24 weeks	Ovulation rate was taken as the gold standard for assessment of ovulation induction result

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Zagazig, Sharkia, Egypt