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Clinical Trials/NCT01468441
NCT01468441
Completed
Not Applicable

Effect of Ovarian Stimulation Using Recombinant FSH and GHRH Antagonist in Alternate Days on ICSI Outcomes

Fertility - Assisted Fertilization Center1 site in 1 country96 target enrollmentSeptember 2011

Overview

Phase
Not Applicable
Intervention
Triptorelin
Conditions
Infertility
Sponsor
Fertility - Assisted Fertilization Center
Enrollment
96
Locations
1
Primary Endpoint
cost of treatment
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2011
End Date
March 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Fertility - Assisted Fertilization Center
Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

GnRH agonist

Administration of GnRH agonist in alternate days, recombinant FSH and hCG microdose for ovarian stimulation.

Intervention: Triptorelin

GnRH antagonist

Daily administration of GnRH antagonist, recombinant FSH and hCG microdose for ovarian stimulation.

Intervention: Cetrorelix

Outcomes

Primary Outcomes

cost of treatment

Time Frame: One month

Secondary Outcomes

  • Implantation and pregnancy rates(2 months)

Study Sites (1)

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