NCT01507376

Comparing the Efficacy of Urinary and Recombinant Human Chorionic Gonadotropin (hCG) on Oocyte Maturity

Comparing the Efficacy of Urinary and Recombinant hCG on Oocyte Maturity for Ovulation Induction in Assisted Reproductive Techniques: a Randomized Clinical Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Royan Institute · Other Government
• Sex: Female
• Age: 20 Years – 37 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• In Vitro Fertilization

Interventions

Type	Name	Description
DRUG	recombinant hCG	recombinant hCG(250 µg Ovitrell)
DRUG	recombinant hCG	recombinant hCG(500 µg Ovitrell)
DRUG	urinary hCG	10,000 IU urinary hCG

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-09-01
• Completion: 2013-06-01
• First posted: 2012-01-10
• Last updated: 2014-04-25

Locations

1 site across 1 country: Iran