Ovarian Stimulation Using Recombinant Follicle-stimulating Hormone (FSH) and Gonadotrophin Releasing Hormone (GnRH) Agonist in Alternate Days

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Drug: Triptorelin; Drug: Cetrorelix

• Registration Number: NCT01468441
• Lead Sponsor: Fertility - Assisted Fertilization Center

Brief Summary

The present prospective study was designed to compare the effects of administering a daily dose of gonadotrophin releasing hormone (GnRH) antagonist vs. an alternate-day dosage of GnRH agonist on ovarian response and in vitro fertilization (IVF) outcome in patients stimulated with recombinant follicle-stimulating hormone (FSH) and human chorionic gonadotrophin (hCG) microdose.

Detailed Description

Inclusion criteria were as follows: women of good physical and mental health, under 37 years old, with regular menstrual cycles of 25-35 days, normal basal FSH and luteinizing hormone (LH) levels, body mass index (BMI) less than 30 kg/m2, presence of both ovaries and intact uterus, absence of polycystic ovaries, endometriosis, or gynaecological / medical disorders and a negative result in a screening for sexually transmitted diseases.

No patient had received any hormone therapy for at least 60 days preceding the study. Eligible patients who agreed to participate were randomized in two treatment groups. Patients were allocated to a GnRH analogue treatment group according to a computer-generated randomization table.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-10-31
• Study First Submitted QC: 2011-11-08
• Study First Posted: 2011-11-09
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-12
• Last Update Posted: 2012-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 96

Inclusion Criteria

• women of good physical and mental health
• under 37 years old, with regular menstrual cycles of 25-35 days
• normal basal FSH and LH levels
• BMI less than 30 kg/m2
• presence of both ovaries and intact uterus
• absence of polycystic ovaries
• endometriosis, or gynaecological / medical disorders and a negative result in a screening for sexually transmitted diseases
• all patients signed a written informed consent form
• no patient had received any hormone therapy for at least 60 days preceding the study.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GnRH agonist	Triptorelin	Administration of GnRH agonist in alternate days, recombinant FSH and hCG microdose for ovarian stimulation.
GnRH antagonist	Cetrorelix	Daily administration of GnRH antagonist, recombinant FSH and hCG microdose for ovarian stimulation.

Primary Outcome Measures

Name	Time	Method
cost of treatment	One month

Secondary Outcome Measures

Name	Time	Method
Implantation and pregnancy rates	2 months

Trial Locations

Locations (1)

Fertility - Assisted Fertilization Center; 🇧🇷 Sao Paulo, Brazil