Infertility Clinical Trial
— FSHOfficial title:
Comparison Between Letrozole and Urinary Purified FSH in Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome: A Randomised Controlled Trial
Verified date | July 2016 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Egypt: Ministry of Higher Education |
Study type | Interventional |
210 women with clomiphene resistant PCOS will be randomly divided into 3 equal groups using computer generated random numbers. Group 1 will receive FSH, group 2 will have Letrozole and group 3 will act as the control group with no intervention.
Status | Completed |
Enrollment | 140 |
Est. completion date | January 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 40 Years |
Eligibility |
Inclusion Criteria: - Clomiphene resistant PCOS. Exclusion Criteria: - Other causes of infertility. - Hyperprolactinaemia. - Allergy to Letrozole or FSH. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Egypt | BeniSuef University hospitals | BeniSuef | |
Egypt | Cairo University Hospitals | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Kar S. Clomiphene citrate or letrozole as first-line ovulation induction drug in infertile PCOS women: A prospective randomized trial. J Hum Reprod Sci. 2012 Sep;5(3):262-5. doi: 10.4103/0974-1208.106338. — View Citation
Vendola K, Zhou J, Wang J, Famuyiwa OA, Bievre M, Bondy CA. Androgens promote oocyte insulin-like growth factor I expression and initiation of follicle development in the primate ovary. Biol Reprod. 1999 Aug;61(2):353-7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ovulation | Regular vaginal ultrasounds will be done starting from the 8th day of starting the drug. | 6 weeks after starting the intervention | No |
Secondary | Pregnancy | 6 months after starting the intervention | No |
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