NCT00823004

Brief Summary

Failure to respond to controlled ovarian hyperstimulation (COH) is still a major concern in assisted reproduction and there is no consensus on the ovarian stimulation choice regime for poor responders. Aim: To evaluate and compare the efficacy of a microdose GnRH agonist flare (MF) and a GnRH antagonist/letrozole (A/L) protocols in poor responders undergoing in vitro fertilization (IVF). Methods: One hundred eighty poor responder patients will be randomized to an ovarian stimulation protocol with either a MF or a letrozole and high dose FSH/hMG and flexible GnRH antagonist protocol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2008

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 15, 2009

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

December 23, 2013

Status Verified

December 1, 2013

Enrollment Period

8 months

First QC Date

January 14, 2009

Last Update Submit

December 20, 2013

Conditions

Ovarian Stimulation

Keywords

controlled ovarian hyperstimulationpregnancy ratePoor respondersGnRH antagonistGnRH agonistletrozolein vitro fertilization

Outcome Measures

Primary Outcomes (1)

  • pregnancy rate

    5 weeks

Secondary Outcomes (1)

  • stimulation outcomes

    2 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

A/L: Poor responders who will receive letrozole and GnRH antagonist for ovarian stimulation

Drug: letrozoleDrug: oral contraceptive (Marvelone)Drug: recombinant FSH or hMGDrug: ganirelix acetate

2

ACTIVE COMPARATOR

MF: In this arm poor responders are treated by microdose GnRH agonist flare protocol

Drug: oral contraceptive (Marvelone)Drug: GnRH agonist (buserelin)Drug: recombinant FSH or hMG

Interventions

letrozoleDRUG

letrozole 5mg/day from day 3 to day 7 of menstrual cycle

Also known as: letrozole (Femara, Novartis, East Hanover, NJ)
1
oral contraceptive (Marvelone)DRUG

oral contraceptive, first 21 days

Also known as: Marvelon
12
GnRH agonist (buserelin)DRUG

50 µg SC twice daily

Also known as: suprefact
2
recombinant FSH or hMGDRUG

recombinant FSH or hMG 300-450 IU/day

Also known as: Gonal F, Merional
12
ganirelix acetateDRUG

GnRH antagonist (ganirelix acetate) when a leading follicle reaches a mean diameter of 14 mm, 0.25 mg per day (Antagon, Organon, West Orange, NJ)

Also known as: Antagon
1

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • at least one previous failed IVF cycle in which three or fewer follicles with a mean diameter of 16 mm were achieved, and/or
  • serum E2 level measured on the day of hCG administration was ≤500 pg/ml

You may not qualify if:

  • day 3 serum FSH level ≥12 mIU/mL
  • there is no age limit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research and clinical center for infertility

Yazd, Yazd Province, 8916877391, Iran

Location

MeSH Terms

Interventions

LetrozolelactitolContraceptives, OralDesogestrelGonadotropin-Releasing HormoneBuserelinfollitropin alfahMG-IBSAganirelix

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsContraceptive Agents, FemaleContraceptive AgentsReproductive Control AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesTherapeutic UsesNorpregnenesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsPituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • homa oskouian, M.D.

    Research and clinical center for infertility

    PRINCIPAL INVESTIGATOR

  • robab davar, MD

    Research and clinical center for infertility

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
fellowship

Study Record Dates

First Submitted

January 14, 2009

First Posted

January 15, 2009

Study Start

June 1, 2008

Primary Completion

February 1, 2009

Study Completion

October 1, 2009

Last Updated

December 23, 2013

Record last verified: 2013-12

Locations

IR(1)