Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment of Poor Ovarian Responders With Corifollitropin Alfa Followed by hpHMG in a Short GnRH Agonist Protocol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01732068
Recruitment Status : Completed
First Posted : November 22, 2012
Last Update Posted : May 9, 2013
Sponsor:
Information provided by (Responsible Party):
Nikolaos P. Polyzos, Universitair Ziekenhuis Brussel

Tracking Information
First Submitted Date  ICMJE November 17, 2012
First Posted Date  ICMJE November 22, 2012
Last Update Posted Date May 9, 2013
Study Start Date  ICMJE July 2012
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2013)
Ongoing pregnancy rate [ Time Frame: 10 to 12 weeks of gestation ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 21, 2012)
Ongoing pregnancy rate [ Time Frame: 10 to 12 weeks after embryo transfer ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2012)
  • Number of oocytes retrieved [ Time Frame: Day of oocyte retrieval ]
  • Cycles with embryo transfer [ Time Frame: Day of Embryo transfer ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Poor Ovarian Responders With Corifollitropin Alfa Followed by hpHMG in a Short GnRH Agonist Protocol
Official Title  ICMJE Phase II Study for the Treatment of Poor Ovarian Responders With Corifollitropin Alfa Followed by hpHMG in a Short GnRH Agonist Protocol
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"

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Infertility
  • Poor Ovarian Response
Intervention  ICMJE
  • Drug: Triptorelin
    Triptorelin 0.1 mg/1 ml solution daily from day 1 or 2 of the cycle onwards
  • Drug: Corifollitropin alfa
    Corifollitropin alfa 150μg (single dose) on day 2 or 3 of the cycle
  • Drug: hpHMG
    300IU hMG daily from day 7 following Corifollitropin alfa until the day of ovulation triggering
Study Arms  ICMJE Experimental: Corifollitropin alfa+hMG
Interventions:
  • Drug: Triptorelin
  • Drug: Corifollitropin alfa
  • Drug: hpHMG
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 7, 2013)
51
Original Estimated Enrollment  ICMJE
 (submitted: November 21, 2012)
50
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries Denmark
 
Administrative Information
NCT Number  ICMJE NCT01732068
Other Study ID Numbers  ICMJE 2012/082
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nikolaos P. Polyzos, Universitair Ziekenhuis Brussel
Study Sponsor  ICMJE Universitair Ziekenhuis Brussel
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nikolaos P Polyzos, MD PhD Universitair Ziekenhuis Brussel
PRS Account Universitair Ziekenhuis Brussel
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP