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

• Sponsor: Royan Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT01507376
• Collaborator: (none)
• Enrollment: 180
• Location: 1
• Arms: 3
• Duration (Months): 32
• Patients Per Site Per Month: 5.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
In Vitro Fertilization	Drug: recombinant hCG; Drug: recombinant hCG; Drug: urinary hCG	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparing the Efficacy of Urinary and Recombinant hCG on Oocyte Maturity for Ovulation Induction in Assisted Reproductive Techniques: a Randomized Clinical Trial
• Study Start Date: Oct 1, 2010
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

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)
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(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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. fertilization rate [in 1 day after oocyte retrieval]

   Evaluation the effect of recombinant hCG on fertilization rate in 1 day after oocyte retrieval

3. implantation rate [4 weeks after embryo transfer]

   Evaluation the effect of recombinant hCG on implantation rate 4 weeks after embryo transfer

4. 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

5. chemical pregnancy rates [2 weeks after embryo transfer]

   Evaluation the effect of recombinant hCG on chemical pregnancy rates 2 weeks after embryo transfer

6. clinical pregnancy rates [4 weeks after embryo transfer]

   Evaluation the effect of recombinant hCG on clinical pregnancy rates 4 weeks after embryo transfer

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 37 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Royan Institute	Tehran		Iran, Islamic Republic of

Sponsors and Collaborators

• Royan Institute

Investigators

• Study Chair: Hamid Gourabi, PhD, Head of Royan Institute
• Study Director: Taraneh Madani, MD, gynecology scientist
• Principal Investigator: Ladan Mohmmadi yeganeh, MSc, Investigator

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Royan Institute
• ClinicalTrials.gov Identifier: NCT01507376
• Other Study ID Numbers: Royan-Emb-012
• First Posted: Jan 10, 2012
• Last Update Posted: Apr 25, 2014
• Last Verified: Oct 1, 2010

• Keywords provided by Royan Institute: Ovulation induction; urinary; hCG; recombinant hCG
• Additional relevant MeSH terms: Chorionic Gonadotropin

Study Results

No Results Posted as of Apr 25, 2014