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: August 17, 2014
Last verified: March 2009
  Purpose

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


Condition Intervention Phase
Infertility
Drug: clomiphene citrate with ethinyl esteradiol
Drug: clomiphene citrate with plasebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluate the Effect of Ethinyl Estradiol on Polycystic Ovary Syndrome Women Undergoing Intrauterine Insemination

Resource links provided by NLM:


Further study details as provided by Royan Institute:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 154
Study Start Date: March 2011
Study Completion Date: February 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Drug administration

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

  Eligibility

Ages Eligible for Study:   25 Years to 30 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01219101

Locations
Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Royan Institute
Investigators
Study Chair: hamid gourabi, PhD President of Royan Institute
Study Director: Ashraf Moieni, MD Scientific Board
  More Information

Additional Information:
No publications provided

Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT01219101     History of Changes
Other Study ID Numbers: Royan-Emb-010
Study First Received: October 9, 2010
Last Updated: August 17, 2014
Health Authority: Iran: Ethics Committee
Iran: Ministry of Health

Keywords provided by Royan Institute:
Ethinyl estradiol
Polycystic ovary syndrome
Intrauterine insemination

Additional relevant MeSH terms:
Infertility
Polycystic Ovary Syndrome
Syndrome
Adnexal Diseases
Cysts
Disease
Endocrine System Diseases
Genital Diseases, Female
Genital Diseases, Male
Gonadal Disorders
Neoplasms
Ovarian Cysts
Ovarian Diseases
Pathologic Processes
Citric Acid
Clomiphene
Enclomiphene
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Ethinyl Estradiol
Polyestradiol phosphate
Zuclomiphene
Anticoagulants
Chelating Agents
Contraceptive Agents
Contraceptive Agents, Female
Estrogen Antagonists
Estrogen Receptor Modulators

ClinicalTrials.gov processed this record on October 29, 2014