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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fertility - Assisted Fertilization Center
ClinicalTrials.gov Identifier:
NCT01468441
First received: October 31, 2011
Last updated: July 12, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention
Infertility
 Drug: Triptorelin
Drug: Cetrorelix

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effect of Ovarian Stimulation Using Recombinant FSH and GHRH Antagonist in Alternate Days on ICSI Outcomes

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by Fertility - Assisted Fertilization Center:

Primary Outcome Measures:
  • cost of treatment [ Time Frame: One month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Implantation and pregnancy rates [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment: 96
Study Start Date: September 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GnRH agonist
Administration of GnRH agonist in alternate days, recombinant FSH and hCG microdose for ovarian stimulation.
 Drug: Triptorelin
Triptorelin (0.1 mg, Gonapeptyl® Daily; Ferring, Kiel, Germany) in alternate-days from Day 1 of the menstrual cycle until the day of hCG administration.
Other Name: Gonapeptyl
Active Comparator: GnRH antagonist
Daily administration of GnRH antagonist, recombinant FSH and hCG microdose for ovarian stimulation.
 Drug: Cetrorelix
When patients presented at least two follicles ≥ 14mm upon scan on days 7- 9, GnRH antagonist (cetrorelix, 0.25 mg/day, Cetrotide®; EMD Serono, Inc, Rockland, MA, USA) administration is started and continued until hCG administration.
Other Name: Cetrotide

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.

  Eligibility

Ages Eligible for Study:   up to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01468441

Locations
Brazil
Fertility - Assisted Fertilization Center
Sao Paulo, Brazil, 01401-002
Sponsors and Collaborators
Fertility - Assisted Fertilization Center
Investigators
Principal Investigator: Luiz Guilherme Maldonado, M.Sc. Fertility - Assisted Fertilization Center
  More Information

No publications provided

Responsible Party: Fertility - Assisted Fertilization Center
ClinicalTrials.gov Identifier: NCT01468441     History of Changes
Other Study ID Numbers: Fert-LG-Doutorado
Study First Received: October 31, 2011
Last Updated: July 12, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by Fertility - Assisted Fertilization Center:
ovarian stimulation
GnRH agonist
GnRH antagonist
hCG microdose
ICSI

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Follicle Stimulating Hormone
Cetrorelix
Triptorelin
Deslorelin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
 Hormone Antagonists
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013