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

In Vitro Fertilization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01507376
• Other study ID #: Royan-Emb-012
• Status: Completed
• Phase: Phase 3
• First received: September 14, 2011
• Last updated: April 24, 2014
• Start date: October 2010
• Est. completion date: June 2013

Study information

• Verified date: October 2010
• Source: Royan Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics CommitteeIran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: June 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 37 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• In Vitro Fertilization

Intervention

Drug:
• recombinant hCG
recombinant hCG(250 µg Ovitrell)
• recombinant hCG
recombinant hCG(500 µg Ovitrell)
• urinary hCG
10,000 IU urinary hCG

Locations

Country	Name	City	State
Iran, Islamic Republic of	Royan Institute	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Royan Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	fertilization rate	Evaluation the effect of recombinant hCG on fertilization rate in 1 day after oocyte retrieval	in 1 day after oocyte retrieval	Yes
Secondary	implantation rate	Evaluation the effect of recombinant hCG on implantation rate 4 weeks after embryo transfer	4 weeks after embryo transfer	Yes
Secondary	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	Yes
Secondary	chemical pregnancy rates	Evaluation the effect of recombinant hCG on chemical pregnancy rates 2 weeks after embryo transfer	2 weeks after embryo transfer	Yes
Secondary	clinical pregnancy rates	Evaluation the effect of recombinant hCG on clinical pregnancy rates 4 weeks after embryo transfer	4 weeks after embryo transfer	Yes

External Links

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