Effect of Adding Isoflavonoids to Clomiphene Citrate for Ovulation Induction in Women With Polycystic Ovary Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sharkia
-
Zagazig, Sharkia, Egypt, 23451
- Faculty of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
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).
|
Rosafem is the only phytoestrogen product with the convenient dose which provides significant improvement of menopausal related symptoms premenstrual syndrome symptoms
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical pregnancy rate
Time Frame: up to 24 weeks
|
defined as the presence of gestational sac containing fetal hearts on ultrasound scan
|
up to 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Endometrial thickness,
Time Frame: up to 24 weeks
|
endometrial thickness is used to monitor infertility treatment
|
up to 24 weeks
|
|
ovulation rate
Time Frame: up to 24 weeks
|
Ovulation rate was taken as the gold standard for assessment of ovulation induction result
|
up to 24 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5111
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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