Infertility Clinical Trial
Official title:
Extended High Dose Letrozole Regimen Versus Short Low Dose Letrozole Regimen as an Adjuvant to GnRH Antagonist Protocol in the Management of Patients With Poor Ovarian Response Undergoing IVF-ET, a Randomized Controlled Trial
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 high dose letrozole regimen (5 mg /day for the first 5 days of cycle and 2.5 mg/day for the subsequent 3 days ) with short low dose letrozole regimen (2,5 mg/day from cycle day 3 to 7 ) as an adjuvant to GnRH antagonist protocol in the management of patients with poor ovarian response undergoing IVF-ET.
Status | Completed |
Enrollment | 136 |
Est. completion date | December 2010 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 30 Years to 42 Years |
Eligibility |
Inclusion Criteria: - Patients who produced less than three mature follicles in response to standard GnRH agonist long protocol in their first IVF cycle Exclusion Criteria: - Age > 42 years - FSH> 12 IU/L - Irregular menstrual cycles - Unilateral ovary - Polycystic ovary syndrome - Endometriosis - Male factor of infertility requiring ICSI - History of recurrent miscarriage - Endocrinologic disorders - Systemic disease contraindicating pregnancy |
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 , Assisted conception unit | Giza, |
Lead Sponsor | Collaborator |
---|---|
Cairo University | Ahmed Elgazzar Hospital |
Egypt,
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
Yarali H, Esinler I, Polat M, Bozdag G, Tiras B. Antagonist/letrozole protocol in poor ovarian responders for intracytoplasmic sperm injection: a comparative study with the microdose flare-up protocol. Fertil Steril. 2009 Jul;92(1):231-5. doi: 10.1016/j.f — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical pregnancy rate per started cycle | Presence of intrauterine gestational sac detected by transvaginal ultrasound | 5 weeks after embryo transfer | No |
Secondary | Ongoing Pregnancy Rate per started cycle | Pregnancies continued beyond 20 weeks gestation | 18 weeks after embryo transfer | No |
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