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Completed

NCT Number: NCT01468441

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

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

Up to 35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fertility - Assisted Fertilization Center

São Paulo, 01401-002, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Triptorelin

Drug

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 names: Gonapeptyl

Cetrorelix

Drug

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 names: Cetrotide

Primary outcomes

  1. cost of treatment

    Time frame: One month

Secondary outcomes

  1. Implantation and pregnancy rates

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

Fertility - Assisted Fertilization Center

Other

Registry information

Official study title

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

Acronym: Gonapeptyl

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 9, 2011
Registry last updated
Jul 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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