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

Phase 3

Completed

• Conditions: In Vitro Fertilization
• Interventions: Drug: recombinant hCG; Drug: urinary hCG

• Registration Number: NCT01507376
• Lead Sponsor: Royan Institute

Brief 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.

Study Timeline

• Status Verified: 2010-10
• Study Start: 2010-10
• Study First Submitted: 2011-09-14
• Study First Submitted QC: 2012-01-05
• Study First Posted: 2012-01-10
• Primary Completion: 2012-09
• Study Completion: 2013-06
• Last Update Submitted: 2014-04-24
• Last Update Posted: 2014-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 180

Inclusion Criteria

• Indication for IVF/ICSI and Long Protocol ovarian stimulation
• Age 20-37
• Body mass index (BMI) ≤ 30 kg/m2
• Regular menstrual cycles of 25-35 days
• Tubal or male factor
• Existence of both ovary and normal uterine cavity
• Basal FSH≥10
• Physical health

Exclusion Criteria

• Poly Cystic Ovarian Syndrome patients
• Contraindications of gonadotropins administration
• Poor response to ovulation induction in recent cycle

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A: recombinant hCG(250 µg Ovitrell)	recombinant hCG	1- Group A consisted of 60 infertile women who received recombinant hCG(250 µg Ovitrelle)
B: recombinant hCG(500 µg Ovitrell)	recombinant hCG	2- Group B consisted of 60 infertile women who received recombinant hCG(500 µg Ovitrelle)
C: urinary hCG	urinary hCG	3- Group C consisted of 60 infertile patients received 10,000 IU urinary hCG

Primary Outcome Measures

Name	Time	Method
Number of mature oocytes	Up to1 hour after oocyte retrieval	evaluation the effect of recombinant hcg on number of oocytes up to 1 hour after oocytes retrieval

Secondary Outcome Measures

Name	Time	Method
number of retrieved oocytes per number of aspirated follicles proportion	up to 1 hour after oocyte retrieval	Evaluation the effect of recombinant hCG to retrieve oocytes per number of aspirated follicles proportion
fertilization rate	in 1 day after oocyte retrieval	Evaluation the effect of recombinant hCG on fertilization rate in 1 day after oocyte retrieval
implantation rate	4 weeks after embryo transfer	Evaluation the effect of recombinant hCG on implantation rate 4 weeks after embryo transfer
OHSS occurrence rate will be compared between three groups	from embryo transfer day up to pregnancy test	Evaluation the effect of recombinant hCG on OHSS occurrence rate will be compared between three groups
chemical pregnancy rates	2 weeks after embryo transfer	Evaluation the effect of recombinant hCG on chemical pregnancy rates 2 weeks after embryo transfer
clinical pregnancy rates	4 weeks after embryo transfer	Evaluation the effect of recombinant hCG on clinical pregnancy rates 4 weeks after embryo transfer

Trial Locations

Locations (1)

Royan Institute; 🇮🇷 Tehran, Iran, Islamic Republic of