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

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04610957
• Other study ID #: 5111
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: April 10, 2019

Study information

• Verified date: October 2020
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: April 10, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Ovulation Induction
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• Rosafem (FEMININE FORMULA)
Rosafem is the only phytoestrogen product with the convenient dose which provides significant improvement of menopausal related symptoms premenstrual syndrome symptoms

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Zagazig	Sharkia

Sponsors (1)

Lead Sponsor	Collaborator
FAlbasri

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rate	defined as the presence of gestational sac containing fetal hearts on ultrasound scan	up to 24 weeks
Secondary	Endometrial thickness,	endometrial thickness is used to monitor infertility treatment	up to 24 weeks
Secondary	ovulation rate	Ovulation rate was taken as the gold standard for assessment of ovulation induction result	up to 24 weeks