Infertility Clinical Trial
Official title:
Evaluate the Effect of Ethinyl Estradiol on Polycystic Ovary Syndrome Women Undergoing Intrauterine Insemination
Verified date | March 2009 |
Source | Royan Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | Iran: Ethics CommitteeIran: Ministry of Health |
Study type | Interventional |
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
Status | Completed |
Enrollment | 95 |
Est. completion date | February 2013 |
Est. primary completion date | November 2012 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 25 Years to 30 Years |
Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Royan Institute | Tehran |
Lead Sponsor | Collaborator |
---|---|
Royan Institute |
Iran, Islamic Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical Pregnancy rate | Usage of clomifen citrate on special days can increase pregnancy rate | 4-6 weeks after embryos transfer(ET) | Yes |
Secondary | Duration of stimulation days | usage of clomiphen citrate with ethyl estradiol in patients with poly cystic ovary can stimulate ovulation | 5 days | Yes |
Secondary | Endometrial thickness | effect of using drugs to increase endometrial thickness | 13 days | Yes |
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