Royan Institute
Tehran, Iran
NCT Number: NCT01509833
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.
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Notify Me37 year–43 year
Female
Interventional
Phase 3
Tehran, Iran
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Administration of rFSH for ovarian stimulation.
Administration of late follicular low dose hCG(100IU) for ovarian stimulation.
Time frame: Up to 2 hours after oocyte retrieval
Evaluation the number of mature oocytes Up to 2 hours after oocyte retrieval
Time frame: Up to 1 hour after oocyte retrieval
Evaluation the number of retrieved oocytes Up to 1 hour after oocyte retrieval
Time frame: Up to 48-72 hours after oocyte retrieval
Evaluation the number of generated embryos up to 48-72 hours after oocyte retrieval.
Time frame: Up to 48-72 hours after oocyte retrieval
Evaluation the Quality of generated embryos up to 48-72 hours after oocyte retrieval.
Time frame: on the time of embryo transfer
Evaluation the number of transferred embryos on the time of embryo transfer.
Time frame: on the time of embryo transfer
Evaluation the quality of transferred embryos on the time of embryo transfer.
Time frame: 4 weeks after embryo transfer
Evaluation the implantation rate 4 weeks after embryo transfer.
Time frame: 2 weeks after embryo transfer
Evaluation the chemical pregnancy rates 2 weeks after embryo transfer.
Time frame: 4 weeks after embryo transfer
Evaluation the clinical pregnancy rates 4 weeks after embryo transfer.
Royan Institute
Other Gov
Efficacy of Low Dose hCG on Oocyte Maturity for Ovarian Stimulation in Poor Responder Women Undergoing ICSI: a Prospective Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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