Overview

Corifollitropin Alfa Followed by Menotropin for Poor Ovarian Responders Trial

Status:
Completed
Trial end date:
2016-05-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Universitair Ziekenhuis Brussel
Collaborators:
Ho Chi Minh City University of Medicine and Pharmacy
University of Medicine and Pharmacy at Ho Chi Minh City
Treatments:
Ganirelix
Criteria
Inclusion Criteria:

- Age less than 40 years

- Fulfillment of the "Bologna criteria" for poor ovarian response.

Based on inclusion criteria two patients' categories are eligible:

1. Women < 40 years old AND ≤3 oocytes in one of the previous cycles AND (Antral follicle
count <7 or antimullerian hormone serum values <1.1 ng/ml)

2. Women <40 years old and ≤3 oocytes in two the previous cycles with maximum ovarian
stimulation

In addition women less than 40 years old will be considered eligible if they had undergone
previous ovarian surgery or chemotherapy (risk factors for poor ovarian response) and have
an AMH<1.1ng/ml or an AFC<7, as suggested by the Bologna criteria

Exclusion Criteria:

- Uterine abnormalities

- Recent history of any current untreated endocrine abnormality

- Unilateral or bilateral hydrosalpinx (visible on transvaginal ultrasound, unless
clipped)

- Contraindications for the use of gonadotropins

- Recent history of severe disease requiring regular treatment