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CompletedNCT01468441GonapeptylUpdated Jul 13, 2012

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

An interventional study of Triptorelin and Cetrorelix in Infertility, sponsored by Fertility - Assisted Fertilization Center. Completed at 1 site in Brazil. Open to female participants aged Up to 35 Years. Per ClinicalTrials.gov, last updated 2012-07-13.

Sponsored by Fertility - Assisted Fertilization Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
Up to 35 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Infertility

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Keywords

  • ovarian stimulation
  • GnRH agonist
  • GnRH antagonist
  • hCG microdose
  • ICSI
03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's enrollment of 96 is below the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

This is the only study on the registry with Fertility - Assisted Fertilization Center as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
96 participants (actual)

Study arms

  • Experimental
    GnRH agonist

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

    Drug: Triptorelin

  • Active comparator
    GnRH antagonist

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

    Drug: Cetrorelix

Interventions

  • DrugTriptorelin

    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.

    Also known as: Gonapeptyl

  • DrugCetrorelix

    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.

    Also known as: Cetrotide

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What researchers measure

Primary outcomes

  1. cost of treatment

    Time frame: One month

Secondary outcomes

  1. Implantation and pregnancy rates

    Time frame: 2 months

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Study locations

1 site
  • Fertility - Assisted Fertilization Center
    Sao Paulo, 01401-002, Brazil
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References and documents

Publications

  • Maldonado LG, Franco JG Jr, Setti AS, Iaconelli A Jr, Borges E Jr. Cost-effectiveness comparison between pituitary down-regulation with a gonadotropin-releasing hormone agonist short regimen on alternate days and an antagonist protocol for assisted fertilization treatments. Fertil Steril. 2013 May;99(6):1615-22. doi: 10.1016/j.fertnstert.2013.01.095. Epub 2013 Feb 5. PubMed 23394779 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01468441
Lead sponsor
Fertility - Assisted Fertilization Center
Responsible party
Sponsor
First posted
Nov 9, 2011
Start date
Sep 2011
Primary completion
Mar 2012
Completion
Mar 2012
Last update
Jul 13, 2012

Study contacts

Luiz Guilherme Maldonado, M.Sc.
principal investigator · Fertility - Assisted Fertilization Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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