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Antagonist/Letrozole in Poor Responders

NCT00823004 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2013-12-23

No results posted yet for this study

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.

Conditions

  • Ovarian Stimulation

Interventions

DRUG

letrozole

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

DRUG

oral contraceptive (Marvelone)

oral contraceptive, first 21 days

DRUG

GnRH agonist (buserelin)

50 µg SC twice daily

DRUG

recombinant FSH or hMG

recombinant FSH or hMG 300-450 IU/day

DRUG

ganirelix acetate

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)

Sponsors & Collaborators

  • Yazd Research & Clinical Center for Infertility

    lead OTHER

Principal Investigators

  • homa oskouian, M.D. · Research and clinical center for infertility

  • robab davar, MD · Research and clinical center for infertility

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2009-02-28
Completion
2009-10-31

Countries

  • Iran

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00823004 on ClinicalTrials.gov