NCT01219101

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 13, 2010

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

November 6, 2014

Status Verified

March 1, 2009

Enrollment Period

1.7 years

First QC Date

October 9, 2010

Last Update Submit

November 5, 2014

Conditions

Infertility

Keywords

Ethinyl estradiolPolycystic ovary syndromeIntrauterine insemination

Outcome Measures

Primary Outcomes (1)

  • Clinical Pregnancy rate

    Usage of clomifen citrate on special days can increase pregnancy rate

    4-6 weeks after embryos transfer(ET)

Secondary Outcomes (2)

  • Duration of stimulation days

    5 days

  • Endometrial thickness

    13 days

Study Arms (2)

clomiphene citrate and ethinyl estradiol

EXPERIMENTAL

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 and placebo

ACTIVE COMPARATOR

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

Interventions

clomiphene citrate with ethinyl esteradiolDRUG

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

Also known as: Drug Administration
clomiphene citrate and ethinyl estradiol
clomiphene citrate with plaseboDRUG

Clomiphene citrate is used in combination of placebo (for 5 days) for induction ovulation of polycystic ovary syndrome women undergoing intrauterine insemination

Also known as: Drug administration
clomiphene citrate and placebo

Eligibility Criteria

Age25 Years - 30 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royan Institute

Tehran, Iran

Location

Related Publications (1)

  • Moini A, Ahmadi F, Jahangiri N, Ahmadi J, Akhoond MR. A randomized controlled trial evaluating the effect of ethinyl estradiol during clomiphene citrate cycles among women with polycystic ovary syndrome. Int J Gynaecol Obstet. 2015 Nov;131(2):129-32. doi: 10.1016/j.ijgo.2015.06.032. Epub 2015 Sep 8.

    PMID: 26391671DERIVED

Related Links

MeSH Terms

Conditions

InfertilityPolycystic Ovary Syndrome

Interventions

Clomiphene

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesOvarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • hamid gourabi, PhD

    President of Royan Institute

    STUDY CHAIR

  • Ashraf Moieni, MD

    Scientific Board

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2010

First Posted

October 13, 2010

Study Start

March 1, 2011

Primary Completion

November 1, 2012

Study Completion

February 1, 2013

Last Updated

November 6, 2014

Record last verified: 2009-03

Locations

IR(1)