Status:
COMPLETED
Corifollitropin Alfa Followed by Menotropin for Poor Ovarian Responders Trial
Lead Sponsor:
Universitair Ziekenhuis Brussel
Collaborating Sponsors:
University of Medicine and Pharmacy at Ho Chi Minh City
Conditions:
Infertility
Poor Ovarian Response
Eligibility:
FEMALE
18-39 years
Phase:
PHASE3
Brief 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) cu...
Detailed Description
Recently, the European Society of Human Reproduction and Embryology developed a new definition in order to select patients suitable for inclusion in future clinical trials as poor ovarian responders, ...
Eligibility Criteria
Inclusion
- Age less than 40 years
- Fulfillment of the "Bologna criteria" for poor ovarian response.
- Based on inclusion criteria two patients' categories are eligible:
- 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)
- 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
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01816321
Start Date
March 1 2013
End Date
May 1 2016
Last Update
June 23 2016
Active Locations (2)
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1
Universitair Ziekenhuis Brussel
Brussels, Belgium, 1090
2
University of Medicine and Pharmacy of Ho Chi Minh City
Ho Chi Minh City, Vietnam