Infertility Clinical Trial
Official title:
Extended Letrozole Regimen Versus Clomiphene Citrate for Superovulation in Patients With Unexplained Infertility Undergoing Intrauterine Insemination
Verified date | July 2011 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Egypt: Institutional Review Board |
Study type | Interventional |
The aim of this randomized controlled trial is to compare the efficacy of extended letrozole regimen (2.5mg/day from cycle day 1 to 9) with clomiphene citrate (100 mg/day from cycle day 3 to 7) in women with unexplained infertility undergoing superovulation and intrauterine insemination .
Status | Completed |
Enrollment | 214 |
Est. completion date | December 2010 |
Est. primary completion date | November 2010 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 37 Years |
Eligibility |
Inclusion Criteria: - Patients with unexplained infertility - Age between 18 - 37 years - Period of infertility > 1 year - Patent Fallopian tubes detected by hysterosalpingography and/or laparoscopy - Normal basal luteinizing hormone (LH), follicle stimulating hormone (FSH) and prolactin concentrations - Normal recent semen analysis (according to World Health Organization criteria) Exclusion Criteria: - FSH> 10 IU/L - Irregular menstrual cycles - Polycystic ovary syndrome - Endometriosis - Endocrinologic disorders - Systemic disease contraindicating pregnancy - Previous IUI cycles - liver or kidney diseases |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Egypt | Ahmed Elgazzar hospital | Cairo | |
Egypt | Cairo university hospital | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University | Ahmed Elgazzar Hospital |
Egypt,
Badawy A, Elnashar A, Totongy M. Clomiphene citrate or aromatase inhibitors for superovulation in women with unexplained infertility undergoing intrauterine insemination: a prospective randomized trial. Fertil Steril. 2009 Oct;92(4):1355-9. doi: 10.1016/j.fertnstert.2008.06.013. Epub 2008 Aug 9. — View Citation
Badawy A, Mosbah A, Tharwat A, Eid M. Extended letrozole therapy for ovulation induction in clomiphene-resistant women with polycystic ovary syndrome: a novel protocol. Fertil Steril. 2009 Jul;92(1):236-9. doi: 10.1016/j.fertnstert.2008.04.065. Epub 2008 Aug 15. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical pregnancy rate | Presence of intrauterine gestational sac detected by transvaginal ultrasound | 5 weeks after intrauterine insemination | No |
Secondary | Ongoing Pregnancy Rate | Pregnancies continued beyond 20 weeks gestation | 18 weeks after intrauterine insemination | No |
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