MedTrace Logo

Corifollitropin Alfa Followed by Menotropin for Poor Ovarian Responders Trial

NCT01816321 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2016-06-23

No results posted yet for this study

Summary

In combination with the existing literature, previous work indicates that 1) women with poor ovarian response fulfilling the "Bologna criteria" have very low pregnancy rates, irrespective of age 2) current treatment protocols demonstrate ongoing pregnancy rates that do not exceed 8.5% and 3) corifollitropin alfa followed by hpHMG might increase ongoing pregnancy rates in young patients (\<40years old) fulfilling the criteria. These findings provide a strong rationale for a definitive large RCT. The COMPORT study will provide conclusive evidence regarding the superiority or not of this novel protocol with corifollitropin alfa followed by hpHMG for the treatment of young poor ovarian responders fulfilling the Bologna criteria.

Conditions

Interventions

DRUG

Corifollitropin alfa

Corifollitropin alfa 150μg on day 2 of the menstrual cycle (stimulation day 1)

DRUG

recombinant FSH

recombinant FSH 300IU/daily from day 2 of the cycle (stimulation day 8)until day of ovulation triggering

DRUG

Ganirelix

Ganirelix 0.25mg/daily from day 7 of the cycle(stimulation day 6) until day of ovulation triggering

DRUG

hp HMG

hp HMG 300IU/daily from day 9 of the cycle (stimulation day 8)until day of ovulation triggering

Sponsors & Collaborators

  • University of Medicine and Pharmacy at Ho Chi Minh City

    collaborator OTHER

  • Universitair Ziekenhuis Brussel

    lead OTHER

Principal Investigators

  • Nikolaos P Polyzos, MD PhD · Universitair Ziekenhuis Brussel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • Belgium
  • Vietnam

Study Locations

More Related Trials

Entities

Diseases

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 NCT01816321 on ClinicalTrials.gov