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

Royan Institute

Status and phase: Completed; Phase 3

Conditions: In Vitro Fertilization

Treatments: Drug: recombinant hCG; Drug: urinary hCG

Study type: Interventional

Funder types: Other

Identifiers

NCT01507376

Royan-Emb-012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 patients

Sex: Female

Ages: 20 to 37 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

180 participants in 3 patient groups

A: recombinant hCG(250 µg Ovitrell)

Experimental group

Description:

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

Treatment:

Drug: recombinant hCG

Drug: recombinant hCG

B: recombinant hCG(500 µg Ovitrell)

Experimental group

Description:

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

Treatment:

Drug: recombinant hCG

Drug: recombinant hCG

C: urinary hCG

Experimental group

Description:

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

Treatment:

Drug: urinary hCG