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

Sponsor
FAlbasri (Other)
Overall Status
Completed
CT.gov ID
NCT04610957
Collaborator
(none)
160
Enrollment
1
Location
2
Arms
3.3
Actual Duration (Months)
49.2
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Rosafem (FEMININE FORMULA)
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Adding Isoflavonoids to Clomiphene Citrate for Ovulation Induction in Women With Polycystic Ovary Syndrome
Actual Study Start Date :
Jan 1, 2019
Actual Primary Completion Date :
Jan 1, 2019
Actual Study Completion Date :
Apr 10, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: The 1st group

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)
Rosafem is the only phytoestrogen product with the convenient dose which provides significant improvement of menopausal related symptoms premenstrual syndrome symptoms
Experimental: The 2nd group

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

Outcome Measures

Primary Outcome Measures

  1. Clinical pregnancy rate [up to 24 weeks]

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

Secondary Outcome Measures

  1. Endometrial thickness, [up to 24 weeks]

    endometrial thickness is used to monitor infertility treatment

  2. ovulation rate [up to 24 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Medicine Zagazig Sharkia Egypt 23451

Sponsors and Collaborators

  • FAlbasri

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
FAlbasri, Resident of Obstetrics and Gynecology, Alkhoms Hospital, Misurata University, Libya, Zagazig University
ClinicalTrials.gov Identifier:
NCT04610957
Other Study ID Numbers:
  • 5111
First Posted:
Nov 2, 2020
Last Update Posted:
Nov 2, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by FAlbasri, Resident of Obstetrics and Gynecology, Alkhoms Hospital, Misurata University, Libya, Zagazig University
Human chorionic gonadotropin
clomiphene Citrate
Isoflavonoids
polycystic ovary syndrome
Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Syndrome

Study Results

No Results Posted as of Nov 2, 2020