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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Royan Institute
ClinicalTrials.gov Identifier:
NCT01219101
First received: October 9, 2010
Last updated: January 22, 2014
Last verified: March 2009

October 9, 2010
January 22, 2014
September 2009
November 2012   (final data collection date for primary outcome measure)
Clinical Pregnancy rate [ Time Frame: 4-6 weeks after embryos transfer(ET) ] [ Designated as safety issue: Yes ]
Usage of clomifen citrate on special days can increase pregnancy rate
Same as current
Complete list of historical versions of study NCT01219101 on ClinicalTrials.gov Archive Site
  • Duration of stimulation days [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
    usage of clomiphen citrate with ethyl estradiol in patients with poly cystic ovary can stimulate ovulation
  • Endometrial thickness [ Time Frame: 13 days ] [ Designated as safety issue: Yes ]
    effect of using drugs to increase endometrial thickness
Same as current
Not Provided
Not Provided
 
The Effect of Ethinyl Estradiol on Polycystic Ovary Syndrome Women Undergoing Intrauterine Insemination
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

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

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Infertility
  • 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 Name: Drug Administration
  • 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 Name: Drug administration
  • 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
    Intervention: Drug: clomiphene citrate with ethinyl esteradiol
  • 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
    Intervention: Drug: clomiphene citrate with plasebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
154
February 2013
November 2012   (final data collection date for primary outcome measure)

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.
Female
25 Years to 30 Years
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01219101
Royan-Emb-010
Yes
Royan Institute
Royan Institute
Not Provided
Study Chair: hamid gourabi, PhD President of Royan Institute
Study Director: Ashraf Moieni, MD Scientific Board
Royan Institute
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP