Comparison of Micro-dose Human Chorionic Gonadotropin (hCG) With HMG in PCOs Patients With Previous Clomiphene Citrate (CC)-Resistant Anovulation
Infertile women with PCOS, who have showed resistance to Clomiphen Citrate (150 mg- 5 days)
in a previous IUI treatment cycle at Royan Institute (Infertility and Reproductive Medicine
Research Centre) will enroll in this prospective randomized clinical trial study and will
randomly be divided into three groups.
The study protocol will be assessed by an independent institutional review board and Royan
ethics committee. All subjects will be given the written informed consent.
Control group (CC/hMG) will receive the 100 mg CC on days 3 to 7 of that cycle but will
receive 150 mg human menopausal gonadotropin (HMG) during days of 7, 8, and 9. One of
experimental Group (group B) will receive a 100 mg dose of CC but will receive a 200 IU
Human chorionic gonadotropin (hCG; Choriomon; IBSA, Switzerland) intramuscular injection
daily when the largest follicle is 12 mm or larger mean diameter. Other experimental group
(Group C) will receive a 100 mg dose of CC but will receive a 200 IU Human chorionic
gonadotropin (hCG; Choriomon; IBSA, Switzerland) intramuscular injection daily From day
9(without attention to follicle size). In both experimental groups HCG administration will
be continued until the largest follicle is 18-20 mm.
Ultrasound measurements of follicle number and growth, ovulation, gestational sac, and serum
hormonal levels will be recorded and compared between two groups.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Multiple pregnancy rates, OHSS rate
Within 20 months after recruiting
Yes
Mahnaz Ashrafi
Principal Investigator
Royan institute, Reproductive Medicine Research Centre, ACECR
Iran: Ministry of Health
Royan-Emb-002
NCT00947713
August 2009
December 2010
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