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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Royan Institute
ClinicalTrials.gov Identifier:
NCT01507376
First received: September 14, 2011
Last updated: April 24, 2014
Last verified: October 2010
  Purpose

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 Intervention Phase
In Vitro Fertilization
Drug: recombinant hCG
Drug: urinary hCG
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Royan Institute:

Primary Outcome Measures:
  • Number of mature oocytes [ Time Frame: Up to1 hour after oocyte retrieval ] [ Designated as safety issue: Yes ]
    evaluation the effect of recombinant hcg on number of oocytes up to 1 hour after oocytes retrieval


Secondary Outcome Measures:
  • number of retrieved oocytes per number of aspirated follicles proportion [ Time Frame: up to 1 hour after oocyte retrieval ] [ Designated as safety issue: Yes ]
    Evaluation the effect of recombinant hCG to retrieve oocytes per number of aspirated follicles proportion

  • fertilization rate [ Time Frame: in 1 day after oocyte retrieval ] [ Designated as safety issue: Yes ]
    Evaluation the effect of recombinant hCG on fertilization rate in 1 day after oocyte retrieval

  • implantation rate [ Time Frame: 4 weeks after embryo transfer ] [ Designated as safety issue: Yes ]
    Evaluation the effect of recombinant hCG on implantation rate 4 weeks after embryo transfer

  • OHSS occurrence rate will be compared between three groups [ Time Frame: from embryo transfer day up to pregnancy test ] [ Designated as safety issue: Yes ]
    Evaluation the effect of recombinant hCG on OHSS occurrence rate will be compared between three groups

  • chemical pregnancy rates [ Time Frame: 2 weeks after embryo transfer ] [ Designated as safety issue: Yes ]
    Evaluation the effect of recombinant hCG on chemical pregnancy rates 2 weeks after embryo transfer

  • clinical pregnancy rates [ Time Frame: 4 weeks after embryo transfer ] [ Designated as safety issue: Yes ]
    Evaluation the effect of recombinant hCG on clinical pregnancy rates 4 weeks after embryo transfer


Enrollment: 180
Study Start Date: October 2010
Study Completion Date: June 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 37 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01507376

Locations
Iran, Islamic Republic of
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
  More Information

Additional Information:
No publications provided by Royan Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT01507376     History of Changes
Other Study ID Numbers: Royan-Emb-012
Study First Received: September 14, 2011
Last Updated: April 24, 2014
Health Authority: Iran: Ethics Committee
Iran: Ministry of Health

Keywords provided by Royan Institute:
Ovulation induction
urinary
hCG
recombinant hCG

Additional relevant MeSH terms:
Chorionic Gonadotropin
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014