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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01219101
Date of registration: 09/10/2010
Prospective Registration: Yes
Primary sponsor: Royan Institute
Public title: The Effect of Ethinyl Estradiol on Polycystic Ovary Syndrome Women Undergoing Intrauterine Insemination
Scientific title: Evaluate the Effect of Ethinyl Estradiol on Polycystic Ovary Syndrome Women Undergoing Intrauterine Insemination
Date of first enrolment: March 2011
Target sample size: 95
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT01219101
Study type:  Interventional
Study design:  Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment  
Phase:  Phase 4
Countries of recruitment
Iran, Islamic Republic of
Contacts
Name:     hamid gourabi, PhD
Address: 
Telephone:
Email:
Affiliation:  President of Royan Institute
Name:     Ashraf Moieni, MD
Address: 
Telephone:
Email:
Affiliation:  Scientific Board
Key inclusion & exclusion criteria

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.



Age minimum: 25 Years
Age maximum: 30 Years
Gender: Female
Health Condition(s) or Problem(s) studied
Infertility
Intervention(s)
Drug: clomiphene citrate with plasebo
Drug: clomiphene citrate with ethinyl esteradiol
Primary Outcome(s)
Clinical Pregnancy rate [Time Frame: 4-6 weeks after embryos transfer(ET)]
Secondary Outcome(s)
Duration of stimulation days [Time Frame: 5 days]
Endometrial thickness [Time Frame: 13 days]
Secondary ID(s)
Royan-Emb-010
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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