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NCT Number: NCT04610957

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

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

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Key information

Conditions

Ovulation Induction Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine

Zagazig, Sharqia Province, 23451, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rosafem (FEMININE FORMULA)

Drug

Rosafem is the only phytoestrogen product with the convenient dose which provides significant improvement of menopausal related symptoms premenstrual syndrome symptoms

Primary outcomes

  1. Clinical pregnancy rate

    Time frame: up to 24 weeks

    defined as the presence of gestational sac containing fetal hearts on ultrasound scan

Secondary outcomes

  1. Endometrial thickness,

    Time frame: up to 24 weeks

    endometrial thickness is used to monitor infertility treatment

  2. ovulation rate

    Time frame: up to 24 weeks

    Ovulation rate was taken as the gold standard for assessment of ovulation induction result

Sponsors and collaborators

Lead sponsor

FAlbasri

Other Gov

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 2, 2020
Registry last updated
Nov 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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