This study is a prospective randomized clinical trial to compare the efficacy of the urinary and recombinant hCG on oocyte quality for ovulation induction in women undergoing IVF/ICSI.
The study population comprised of all infertile patients aged 20-37 years which underwent of in-vitro fertilization in royan institute, Tehran Iran. In this study all patients were treated with a long stimulation protocol in which GnRH-analogue (Buserelin subcutaneous, 0.5cc daily) was given as a pre-treatment and recombinant FSH (rFSH) administration was started when pituitary desensitization was confirmed. From the 7th day of stimulation in both groups, daily monitoring of follicle size by ultrasound was performed and the dose of rFSH was adjusted according to the response of each patient. When at least two follicles \> 18 mm diameter were seen, ovulation was triggered with hCG and patients allocated into three different study groups as per the following: 1. Group A consisted of 60 women who received recombinant hCG(250 µg Ovitrelle) 2. Group B consisted of 60 women who received recombinant hCG(500 µg Ovitrelle) 3. Group C consisted of 60 patients received 10,000 IU urinary hCG Oocyte retrieval performed about 34-36 hours after hCG administration and then oocytes were assessed for nuclear maturity. Embryos transferred 2-3 days thereafter. Data collection will be performed by using questionnaire to be filled as per the available records and laboratory results. Data analysis will be done through descriptive and perceptive statistical methods by using SPSS software version 16 for windows.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
recombinant hCG(250 µg Ovitrell)
recombinant hCG(500 µg Ovitrell)
10,000 IU urinary hCG
Royan Institute
Tehran, Iran
Number of mature oocytes
evaluation the effect of recombinant hcg on number of oocytes up to 1 hour after oocytes retrieval
Time frame: Up to1 hour after oocyte retrieval
number of retrieved oocytes per number of aspirated follicles proportion
Evaluation the effect of recombinant hCG to retrieve oocytes per number of aspirated follicles proportion
Time frame: up to 1 hour after oocyte retrieval
fertilization rate
Evaluation the effect of recombinant hCG on fertilization rate in 1 day after oocyte retrieval
Time frame: in 1 day after oocyte retrieval
implantation rate
Evaluation the effect of recombinant hCG on implantation rate 4 weeks after embryo transfer
Time frame: 4 weeks after embryo transfer
OHSS occurrence rate will be compared between three groups
Evaluation the effect of recombinant hCG on OHSS occurrence rate will be compared between three groups
Time frame: from embryo transfer day up to pregnancy test
chemical pregnancy rates
Evaluation the effect of recombinant hCG on chemical pregnancy rates 2 weeks after embryo transfer
Time frame: 2 weeks after embryo transfer
clinical pregnancy rates
Evaluation the effect of recombinant hCG on clinical pregnancy rates 4 weeks after embryo transfer
Time frame: 4 weeks after embryo transfer
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