A Phase 3 interventional study of rFSH and hCG in Infertility, sponsored by Royan Institute. Completed at 1 site in Iran. Open to female participants aged 37 Years to 43 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-01-13.
Sponsored by Royan Institute · Phase 3, Interventional, and Treatment
This study is a prospective, randomized, parallel, controlled trial to assess the efficacy of the late follicular phase administration of low dose hCG on oocyte maturity for ovarian stimulation in 73 poor respond patients undergoing intracytoplasmic sperm injection (ICSI) treatment.
In this study all eligible patients were randomly allocated into three study groups by a permuted block randomization method: group A (control group) received only recombinant FSH, group B received rFSH supplemented by 100IU hCG in the late follicular phase. Group C received rFSH supplemented by 200IU hCG in the late follicular phase.
All of the patients underwent a standard long protocol and received GnRH-a (Suprefact), 0.5cc subcutaneous, started from the day 17 of the preceding cycle and ovulation induction was started 14 days thereafter.
Patients were categorized according to the following stimulation protocols:
Group A (control group): which 300 IU r-FSH was administered for the first 5 days of the stimulation cycle. Then the first ultrasound scan was performed to monitor response. At this stage the dose of rFSH adjusted according to the ovarian response and continued until the day of ovulatory hCG administration.
Group B: rFSH supplemented with daily administration of 100 IU hCG in the late follicular phase based on the follicle size (14mm).
Group C: rFSH supplemented with daily administration of 200 IU hCG in the late follicular phase based on the follicle size (14mm).
To assess the pregnancy outcomes, serum hCG was measured 2 weeks after embryo transfer. Clinical pregnancy was defined by the observation of sac with fetal heart rate on ultrasonography 4 weeks after embryo transfer.
2,540 studies on the registry are indexed under Infertility; 405 are open to participants now.
This study's enrollment of 73 is below the median of 120 across 1,722 interventional studies indexed under Infertility.
Browse Infertility studies →Royan Institute is the lead sponsor of 94 studies on the registry; 3 are open to participants now.
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Inclusion Criteria:
Administration of recombinant FSH for ovarian stimulation.
Drug: rFSH
Administration of late follicular low dose hCG(100U) for ovarian stimulation.
Drug: hCG
Administration of late follicular low dose hCG(200IU) for ovarian stimulation.
Drug: hCG
Number of mature oocytes
Evaluation the number of mature oocytes Up to 2 hours after oocyte retrieval
Time frame: Up to 2 hours after oocyte retrieval
Number of retrieved oocytes
Evaluation the number of retrieved oocytes Up to 1 hour after oocyte retrieval
Time frame: Up to 1 hour after oocyte retrieval
Number of generated embryos
Evaluation the number of generated embryos up to 48-72 hours after oocyte retrieval.
Time frame: Up to 48-72 hours after oocyte retrieval
Quality of generated embryos
Evaluation the Quality of generated embryos up to 48-72 hours after oocyte retrieval.
Time frame: Up to 48-72 hours after oocyte retrieval
Number of transferred embryos
Evaluation the number of transferred embryos on the time of embryo transfer.
Time frame: on the time of embryo transfer
Quality of transferred embryos
Evaluation the quality of transferred embryos on the time of embryo transfer.
Time frame: on the time of embryo transfer
implantation rate
Evaluation the implantation rate 4 weeks after embryo transfer.
Time frame: 4 weeks after embryo transfer
chemical pregnancy rates
Evaluation the chemical pregnancy rates 2 weeks after embryo transfer.
Time frame: 2 weeks after embryo transfer
clinical pregnancy rates
Evaluation the clinical pregnancy rates 4 weeks after embryo transfer.
Time frame: 4 weeks after embryo transfer
This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Follitropin beta · Chorionic Gonadotropin
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