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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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In Vitro Fertilization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A: recombinant hCG(250 µg Ovitrell)

1- Group A consisted of 60 infertile women who received recombinant hCG(250 µg Ovitrelle)

Group Type EXPERIMENTAL

recombinant hCG

Intervention Type DRUG

recombinant hCG(250 µg Ovitrell)

B: recombinant hCG(500 µg Ovitrell)

2- Group B consisted of 60 infertile women who received recombinant hCG(500 µg Ovitrelle)

Group Type EXPERIMENTAL

recombinant hCG

Intervention Type DRUG

recombinant hCG(500 µg Ovitrell)

C: urinary hCG

3- Group C consisted of 60 infertile patients received 10,000 IU urinary hCG

Group Type EXPERIMENTAL

urinary hCG

Intervention Type DRUG

10,000 IU urinary hCG

Interventions

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recombinant hCG

recombinant hCG(250 µg Ovitrell)

Intervention Type DRUG

recombinant hCG

recombinant hCG(500 µg Ovitrell)

Intervention Type DRUG

urinary hCG

10,000 IU urinary hCG

Intervention Type DRUG

Eligibility Criteria

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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