Phytoestrogens as an Alternative to Estradiol in Ovulation Induction in PCOS (PCOS)

March 22, 2017 updated by: Ahmed Maged, Cairo University

Phytoestrogens as an Alternative to Estradiol in Reversing the Antiestrogenic Effect of Clomid on Endometrium in Ovulation Induction in Cases of Polycystic Ovarian Syndrome

Prospective study conducted on 150 women with polycystic ovarian syndrome (PCOS) were randomly divided into 3 groups: group I (50 women) received clomiphene citrate (CC) only 50 mg orally every 8 hours started from cycle day 3 for 5 days, group II (50 women) received 2mg estradiol valerate daily from cycle day 7 - 11 in addition to CC and group III (50 women) received phytoestrogen (20mg of cimifuga racemosa from day 1- 12) in addition to CC.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prospective study conducted on 150 women with PCOS were randomly divided into 3 groups: group I (50 women) received CC only50 mg orally every 8 hours started from cycle day 3 for 5 days, group II (50 women) received 2mg estradiol valerate daily from cycle day 7 - 11 in addition to CC and group III (50 women) received phytoestrogen (20mg of cimifuga racemosa from day 1- 12) in addition to CC.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 37 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Women with both 1ry and 2ry infertility were included. All women were between 20 and 37 years old.

Exclusion Criteria:

women with endocrinological abnormalities as thyroid dysfunction or abnormal prolactin levels, those with hypothalamic or pituitary dysfunctions evaluated by low gonadotropin level, other causes of infertility as tubal factor evaluated by HSG or laparoscopy, abnormal uterine cavity evaluated by sonohystrography or hysteroscopy and male factor evaluated by semen analysis. Women with ovarian cysts were also excluded from the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: clomiphene citrate
only50 mg orally every 8 hours started from cycle day 3 for 5 days
Drug: clomiphene citrate
50 mg orally every 8 hours started from cycle day 3 for 5 days
Other Names:
  • clomid
Active Comparator: estradiol valerate and CC
2mg estradiol valerate orally daily from cycle day 7 - 11 in addition to CC
Drug: clomiphene citrate
50 mg orally every 8 hours started from cycle day 3 for 5 days
Other Names:
  • clomid
Drug: estradiol valerate
2mg from cycle day 7 to day 11
Other Names:
  • cycloprogynova
Active Comparator: Phytoestrogen and CC
20mg of cimifuga racemosaorally from day 1- 12) in addition to CC
Drug: clomiphene citrate
50 mg orally every 8 hours started from cycle day 3 for 5 days
Other Names:
  • clomid
Drug: phytoestrogen
20mg of cimifuga racemosa from day 1- 12
Other Names:
  • Klimadynon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
endometrial thickness
Time Frame: day 14 of menstrual cycle
day 14 of menstrual cycle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

January 25, 2015

First Submitted That Met QC Criteria

January 30, 2015

First Posted (Estimate)

February 2, 2015

Study Record Updates

Last Update Posted (Actual)

March 24, 2017

Last Update Submitted That Met QC Criteria

March 22, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 222 (Other Grant/Funding Number: MS Society UK)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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