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

FAlbasri

Status: Completed

Conditions: Ovulation Induction; Polycystic Ovary Syndrome

Treatments: Drug: Rosafem (FEMININE FORMULA)

Study type: Interventional

Funder types: Other

Identifiers

NCT04610957

5111

Details and patient eligibility

About

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

Full 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.

Enrollment: 160 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

The 1st group

Experimental group

Description:

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

Treatment:

Drug: Rosafem (FEMININE FORMULA)

The 2nd group

Experimental group

Description:

included eighty (80) women receiving Clomiphene citrate only, at dose (100 mg/day, starting from day 3 to day 7 of the cycle).

Treatment:

Drug: Rosafem (FEMININE FORMULA)