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

Primary Purpose

Ovulation Induction, Polycystic Ovary Syndrome

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Rosafem (FEMININE FORMULA)

About this trial

This is an interventional treatment trial for Ovulation Induction focused on measuring Human chorionic gonadotropin, clomiphene Citrate, Isoflavonoids, polycystic ovary syndrome

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

The 1st group

The 2nd group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Clinical pregnancy rate

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

Secondary Outcome Measures

Endometrial thickness,

endometrial thickness is used to monitor infertility treatment

ovulation rate

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

Full Information

NCT ID

NCT04610957

First Posted

October 1, 2020

Last Updated

October 26, 2020

Sponsor

FAlbasri

1. Study Identification

Unique Protocol Identification Number

NCT04610957

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

January 1, 2019 (Actual)

Primary Completion Date

January 1, 2019 (Actual)

Study Completion Date

April 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

FAlbasri

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ovulation Induction, Polycystic Ovary Syndrome

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

160 (Actual)

8. Arms, Groups, and Interventions

Arm Title

The 1st group

Arm Type

Experimental

Arm Description

Arm Title

The 2nd group

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Rosafem (FEMININE FORMULA)

Intervention Description

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

Primary Outcome Measure Information:

Title

Clinical pregnancy rate

Description

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

Time Frame

up to 24 weeks

Secondary Outcome Measure Information:

Title

Endometrial thickness,

Description

endometrial thickness is used to monitor infertility treatment

Time Frame

up to 24 weeks

Title

ovulation rate

Description

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

Time Frame

up to 24 weeks

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Faculty of Medicine

City

Zagazig

State/Province

Sharkia

ZIP/Postal Code

23451

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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