The Effect of Ethinyl Estradiol on Polycystic Ovary Syndrome Women Undergoing Intrauterine Insemination
Primary Purpose
Infertility
Status
Completed
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
clomiphene citrate with ethinyl esteradiol
clomiphene citrate with plasebo
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring Ethinyl estradiol, Polycystic ovary syndrome, Intrauterine insemination
Eligibility 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.
Sites / Locations
- Royan Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
clomiphene citrate and ethinyl estradiol
clomiphene citrate and placebo
Arm Description
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
Clomiphene citrate is used in combination of placebo (for 5 days) for induction ovulation of polycystic ovary syndrome women undergoing intrauterine insemination
Outcomes
Primary Outcome Measures
Clinical Pregnancy rate
Usage of clomifen citrate on special days can increase pregnancy rate
Secondary Outcome Measures
Duration of stimulation days
usage of clomiphen citrate with ethyl estradiol in patients with poly cystic ovary can stimulate ovulation
Endometrial thickness
effect of using drugs to increase endometrial thickness
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01219101
Brief Title
The Effect of Ethinyl Estradiol on Polycystic Ovary Syndrome Women Undergoing Intrauterine Insemination
Official Title
Evaluate the Effect of Ethinyl Estradiol on Polycystic Ovary Syndrome Women Undergoing Intrauterine Insemination
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royan Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Ethinyl estradiol, Polycystic ovary syndrome, Intrauterine insemination
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
95 (Actual)
8. Arms, Groups, and Interventions
Arm Title
clomiphene citrate and ethinyl estradiol
Arm Type
Experimental
Arm Description
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
Arm Title
clomiphene citrate and placebo
Arm Type
Active Comparator
Arm Description
Clomiphene citrate is used in combination of placebo (for 5 days) for induction ovulation of polycystic ovary syndrome women undergoing intrauterine insemination
Intervention Type
Drug
Intervention Name(s)
clomiphene citrate with ethinyl esteradiol
Other Intervention Name(s)
Drug Administration
Intervention Description
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 Type
Drug
Intervention Name(s)
clomiphene citrate with plasebo
Other Intervention Name(s)
Drug administration
Intervention Description
Clomiphene citrate is used in combination of placebo (for 5 days) for induction ovulation of polycystic ovary syndrome women undergoing intrauterine insemination
Primary Outcome Measure Information:
Title
Clinical Pregnancy rate
Description
Usage of clomifen citrate on special days can increase pregnancy rate
Time Frame
4-6 weeks after embryos transfer(ET)
Secondary Outcome Measure Information:
Title
Duration of stimulation days
Description
usage of clomiphen citrate with ethyl estradiol in patients with poly cystic ovary can stimulate ovulation
Time Frame
5 days
Title
Endometrial thickness
Description
effect of using drugs to increase endometrial thickness
Time Frame
13 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hamid gourabi, PhD
Organizational Affiliation
President of Royan Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ashraf Moieni, MD
Organizational Affiliation
Scientific Board
Official's Role
Study Director
Facility Information:
Facility Name
Royan Institute
City
Tehran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
26391671
Citation
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.
Results Reference
derived
Links:
URL
http://www.royaninstitute.org
Description
Royan Institute
Learn more about this trial
The Effect of Ethinyl Estradiol on Polycystic Ovary Syndrome Women Undergoing Intrauterine Insemination
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