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

Phase 4
25 Years
30 Years
Not Enrolling

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Trial Information

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

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

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

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

- Women who had uterine or tubal abnormalities on hysterosalpingography, and women who
had a body mass index of >30 kg/m2.

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Clinical Pregnancy rate

Outcome Description:

Usage of clomifen citrate on special days can increase pregnancy rate

Outcome Time Frame:

4-6 weeks after embryos transfer(ET)

Safety Issue:


Principal Investigator

hamid gourabi, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

President of Royan Institute


Iran: Ethics Committee

Study ID:




Start Date:

September 2009

Completion Date:

April 2011

Related Keywords:

  • Infertility
  • Ethinyl estradiol
  • Polycystic ovary syndrome
  • Intrauterine insemination
  • Infertility
  • Polycystic Ovary Syndrome