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

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.

Study Overview

• Status: Completed
• Conditions: In Vitro Fertilization
• Intervention / Treatment: Drug: recombinant hCG; Drug: recombinant hCG; Drug: urinary hCG

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 Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 3

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Royan Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 37 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of mature oocytes	evaluation the effect of recombinant hcg on number of oocytes up to 1 hour after oocytes retrieval	Up to1 hour after oocyte retrieval

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to 1 hour after oocyte retrieval
fertilization rate	Evaluation the effect of recombinant hCG on fertilization rate in 1 day after oocyte retrieval	in 1 day after oocyte retrieval
implantation rate	Evaluation the effect of recombinant hCG on implantation rate 4 weeks after embryo transfer	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	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	2 weeks after embryo transfer
clinical pregnancy rates	Evaluation the effect of recombinant hCG on clinical pregnancy rates 4 weeks after embryo transfer	4 weeks after embryo transfer

Collaborators and Investigators

• Sponsor: Royan Institute
• Investigators: Study Director: Taraneh Madani, MD, gynecology scientist; Principal Investigator: Ladan Mohmmadi yeganeh, MSc, Investigator

Publications and helpful links

General Publications

• Madani T, Mohammadi Yeganeh L, Ezabadi Z, Hasani F, Chehrazi M. Comparing the efficacy of urinary and recombinant hCG on oocyte/follicle ratio to trigger ovulation in women undergoing intracytoplasmic sperm injection cycles: a randomized controlled trial. J Assist Reprod Genet. 2013 Feb;30(2):239-45. doi: 10.1007/s10815-012-9919-3. Epub 2012 Dec 29.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: September 14, 2011
• First Submitted That Met QC Criteria: January 5, 2012
• First Posted (Estimate): January 10, 2012

Study Record Updates

• Last Update Posted (Estimate): April 25, 2014
• Last Update Submitted That Met QC Criteria: April 24, 2014
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: hCG; Ovulation induction; urinary; recombinant hCG
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Chorionic Gonadotropin
• Other Study ID Numbers: Royan-Emb-012