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

NCT04610957 | Completed

• 1 other identifier: 5111
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Conditions

Ovulation Induction; Polycystic Ovary Syndrome

Keywords

Human chorionic gonadotropin; clomiphene Citrate; Isoflavonoids; polycystic ovary syndrome

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy rate

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

  up to 24 weeks

Secondary Outcomes (2)

• Endometrial thickness,

  up to 24 weeks

• ovulation rate

  up to 24 weeks

Study Arms (2)

The 1st group

EXPERIMENTAL

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

Drug: Rosafem (FEMININE FORMULA)

The 2nd group

EXPERIMENTAL

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

Drug: Rosafem (FEMININE FORMULA)

Interventions

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

The 1st group; The 2nd group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patient aged 18- 35 years old with primary or secondary infertility

You may not qualify if:

• 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

Sponsors & Collaborators

• FAlbasri: lead

Study Sites (1)

Faculty of Medicine

Zagazig, Sharqia Province, 23451, Egypt

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident of Obstetrics and Gynecology, Alkhoms Hospital, Misurata University, Libya

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: November 2, 2020
• Study Start: January 1, 2019
• Primary Completion: January 1, 2019
• Study Completion: April 10, 2019
• Last Updated: November 2, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)