NCT01468441

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 9, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

July 13, 2012

Status Verified

July 1, 2012

Enrollment Period

6 months

First QC Date

October 31, 2011

Last Update Submit

July 12, 2012

Conditions

Infertility

Keywords

ovarian stimulationGnRH agonistGnRH antagonisthCG microdoseICSI

Outcome Measures

Primary Outcomes (1)

  • cost of treatment

    One month

Secondary Outcomes (1)

  • Implantation and pregnancy rates

    2 months

Study Arms (2)

GnRH agonist

EXPERIMENTAL

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

Drug: Triptorelin

GnRH antagonist

ACTIVE COMPARATOR

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

Drug: Cetrorelix

Interventions

TriptorelinDRUG

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
GnRH agonist
CetrorelixDRUG

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
GnRH antagonist

Eligibility Criteria

AgeUp to 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fertility - Assisted Fertilization Center

São Paulo, São Paulo, 01401-002, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 23394779DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Triptorelin Pamoatecetrorelix

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Luiz Guilherme Maldonado, M.Sc.

    Fertility - Assisted Fertilization Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2011

First Posted

November 9, 2011

Study Start

September 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

July 13, 2012

Record last verified: 2012-07

Locations

BR(1)