The Effect of Ethinyl Estradiol on Polycystic Ovary Syndrome Women Undergoing Intrauterine Insemination

November 5, 2014 updated by: Royan Institute

Evaluate the Effect of Ethinyl Estradiol on Polycystic Ovary Syndrome Women Undergoing Intrauterine Insemination

According to the studies CC is successful at inducing ovulation in 50%-75% of cases, but only 30-40% becomes pregnant. The difference has been attributed to a negative action of clomifen citrate(CC) in the form of prolonged antiestrogenic effects on endometrial receptivity. For avoiding of these negative effects, giving ethinyl estradiol in sufficient dosages may be effective. The purpose of this study is comparing pregnancy rates after IUI in women who use CC alone and those who use CC in combination with ethinyl estradiol

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The proposal of This study approved by our institutional review boards and institution's ethical committee, and all Participants will sign a written consent before enter to study. All patients will be randomly divided into two groups, A and B. Stimulation will begin on day 3 with the administration of 100 mg of clomifen citrate(CC) daily for 5 days. On day 8, ethinyl estradiol will be given daily for 5 days in group A and placebo will be given for 5 days in group B. Plasma levels of estradiol(E2), Luteinizing hormone (LH) and Follicle-stimulating hormone (FSH) will be evaluated on days 3 and 13 of the menstrual cycle. Ultrasound examination will be done on days 3, 13 and days of HCG administration and IUI for determining of endometrial thickness, number of follicles and size of the dominant follicle.

When the diameter of at least one follicle reached equal or greater than 18 mm, human chronic gonadotrophin (HCG) 10,000 IU will be administered.

The pulsatility index also will be recorded in both uterine arteries on day of HCG administration. A single IUI will be performed 24-36 hours after the administration of hCG. Pregnancy will be confirmed by increasing level of concentration of serum βHCG which will be assessed 14 days after IUI

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

25 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • The patients with first treatment cycle
  • Age between 25 and 30 years,
  • Infertility for at least 2 years' duration,
  • Oligomenorrhea or amenorrhea associated with a positive Progesterone challenge test
  • Women with normal concentrations of prolactin, free thyroxin and thyroid-stimulating hormone (TSH)

Exclusion Criteria:

  • Women whose partners had an abnormal semen analysis according to World Health Organization
  • Women who had uterine or tubal abnormalities on hysterosalpingography, and women who had a body mass index of >30 kg/m2.

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: clomiphene citrate and ethinyl estradiol
Clomiphene citrate is used in combination of ethinyl estradiol (0.05 mg for 5 days) for induction ovulation of polycystic ovary syndrome women undergoing intrauterine insemination
Drug: clomiphene citrate with ethinyl esteradiol
Clomiphene citrate is used in combination of ethinyl estradiol (0.05 mg for 5 days) for induction ovulation of polycystic ovary syndrome women undergoing intrauterine insemination
Other Names:
  • Drug Administration
Active Comparator: clomiphene citrate and placebo
Clomiphene citrate is used in combination of placebo (for 5 days) for induction ovulation of polycystic ovary syndrome women undergoing intrauterine insemination
Drug: clomiphene citrate with plasebo
Clomiphene citrate is used in combination of placebo (for 5 days) for induction ovulation of polycystic ovary syndrome women undergoing intrauterine insemination
Other Names:
  • Drug administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Pregnancy rate
Time Frame: 4-6 weeks after embryos transfer(ET)
Usage of clomifen citrate on special days can increase pregnancy rate
4-6 weeks after embryos transfer(ET)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of stimulation days
Time Frame: 5 days
usage of clomiphen citrate with ethyl estradiol in patients with poly cystic ovary can stimulate ovulation
5 days
Endometrial thickness
Time Frame: 13 days
effect of using drugs to increase endometrial thickness
13 days

Collaborators and Investigators

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

Sponsor

Royan Institute

Investigators

  • Study Chair: hamid gourabi, PhD, President of Royan Institute
  • Study Director: Ashraf Moieni, MD, Scientific Board

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

March 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

October 9, 2010

First Submitted That Met QC Criteria

October 9, 2010

First Posted (Estimate)

October 13, 2010

Study Record Updates

Last Update Posted (Estimate)

November 6, 2014

Last Update Submitted That Met QC Criteria

November 5, 2014

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Royan-Emb-010

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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