Back to resultsTreatment of Poor Ovarian Responders With Corifollitropin Alfa Followed by hpHMG in a Short GnRH Agonist Protocol
Primary Purpose
Infertility, Poor Ovarian Response
Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Triptorelin
Corifollitropin alfa
hpHMG
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring Poor ovarian response, Poor ovarian responders, Bologna criteria for poor ovarian response
Eligibility Criteria
Inclusion Criteria:
Patients should fulfill the "Bologna criteria" for poor ovarian response
At least two of the following three features must be present:
i. Advanced maternal age (≥40 years) or any other risk factor for POR (poor ovarian response); ii. A previous POR (≤3 oocytes with a conventional stimulation protocol); iii. An abnormal ovarian reserve test (i.e. AFC <7 follicles or AMH <1.1 ng/ml).
Two episodes of POR after maximal stimulation are sufficient to define a patient as poor responder in the absence of advanced maternal age or abnormal ORT (ovarian reserve test).
Exclusion Criteria:
-
Sites / Locations
- Centre for Reproductive Medicine UZ Brussel
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Corifollitropin alfa+hMG
Arm Description
Outcomes
Primary Outcome Measures
Ongoing pregnancy rate
Secondary Outcome Measures
Number of oocytes retrieved
Cycles with embryo transfer
Full Information
NCT ID
NCT01732068
First Posted
November 17, 2012
Last Updated
May 7, 2013
Sponsor
Universitair Ziekenhuis Brussel
1. Study Identification
Unique Protocol Identification Number
NCT01732068
Brief Title
Treatment of Poor Ovarian Responders With Corifollitropin Alfa Followed by hpHMG in a Short GnRH Agonist Protocol
Official Title
Phase II Study for the Treatment of Poor Ovarian Responders With Corifollitropin Alfa Followed by hpHMG in a Short GnRH Agonist Protocol
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitair Ziekenhuis Brussel
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the present study is to examine the level of ovarian response and the pregnancy rates among poor ovarian responders treated with a novel treatment protocol with 150μg corifollitropin alfa followed by 300IU hMG in a short GnRH agonist protocol.
Detailed Description
Corifollitropin alfa reaches maximum concentrations (Cmax), between 25 and 45 h after injection , a time interval which is significantly shorter as compared to treatment with rFSH. The investigators hypothesized that this rapid increase in the serum FSH concentration may result in a significantly higher exposure of the small antral follicles to constant high levels of FSH during the early follicular phase, securing not only the recruitment of the follicles, but also the continued growth.
In the current study the investigators examine whether administration of corifollitropin followed by 300IU hMG in a short GnRH agonist protocol may result in acceptable pregnancy rates in poor ovarian responders fulfilling the "Bologna criteria"
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Poor Ovarian Response
Keywords
Poor ovarian response, Poor ovarian responders, Bologna criteria for poor ovarian response
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Corifollitropin alfa+hMG
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Triptorelin
Intervention Description
Triptorelin 0.1 mg/1 ml solution daily from day 1 or 2 of the cycle onwards
Intervention Type
Drug
Intervention Name(s)
Corifollitropin alfa
Intervention Description
Corifollitropin alfa 150μg (single dose) on day 2 or 3 of the cycle
Intervention Type
Drug
Intervention Name(s)
hpHMG
Intervention Description
300IU hMG daily from day 7 following Corifollitropin alfa until the day of ovulation triggering
Primary Outcome Measure Information:
Title
Ongoing pregnancy rate
Time Frame
10 to 12 weeks of gestation
Secondary Outcome Measure Information:
Title
Number of oocytes retrieved
Time Frame
Day of oocyte retrieval
Title
Cycles with embryo transfer
Time Frame
Day of Embryo transfer
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients should fulfill the "Bologna criteria" for poor ovarian response
At least two of the following three features must be present:
i. Advanced maternal age (≥40 years) or any other risk factor for POR (poor ovarian response); ii. A previous POR (≤3 oocytes with a conventional stimulation protocol); iii. An abnormal ovarian reserve test (i.e. AFC <7 follicles or AMH <1.1 ng/ml).
Two episodes of POR after maximal stimulation are sufficient to define a patient as poor responder in the absence of advanced maternal age or abnormal ORT (ovarian reserve test).
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nikolaos P Polyzos, MD PhD
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Reproductive Medicine UZ Brussel
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Treatment of Poor Ovarian Responders With Corifollitropin Alfa Followed by hpHMG in a Short GnRH Agonist Protocol
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