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

• ClinicalTrials.gov Identifier: NCT01732068
• Recruitment Status: Completed
• First Posted: November 22, 2012
• Last Update Posted: May 9, 2013
• Sponsor: Universitair Ziekenhuis Brussel
• Information provided by (Responsible Party): Nikolaos P. Polyzos, Universitair Ziekenhuis Brussel

Tracking Information

• First Submitted Date: November 17, 2012
• First Posted Date: November 22, 2012
• Last Update Posted Date: May 9, 2013
• Study Start Date: July 2012
• Actual Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 16, 2013): Ongoing pregnancy rate [ Time Frame: 10 to 12 weeks of gestation ]
• Original Primary Outcome Measures (submitted: November 21, 2012): Ongoing pregnancy rate [ Time Frame: 10 to 12 weeks after embryo transfer ]

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Infertility
• Poor Ovarian Response

Intervention

• 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

Experimental: Corifollitropin alfa+hMG

Interventions:

• Drug: Triptorelin
• Drug: Corifollitropin alfa
• Drug: hpHMG

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 7, 2013): 51
• Original Estimated Enrollment (submitted: November 21, 2012): 50
• Actual Study Completion Date: May 2013
• Actual Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)

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:

-

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium
• Removed Location Countries: Denmark

Administrative Information

• NCT Number: NCT01732068
• Other Study ID Numbers: 2012/082
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Nikolaos P. Polyzos, Universitair Ziekenhuis Brussel
• Study Sponsor: Universitair Ziekenhuis Brussel
• Collaborators: Not Provided

Investigators

• Principal Investigator: Nikolaos P Polyzos, MD PhD; Universitair Ziekenhuis Brussel

• PRS Account: Universitair Ziekenhuis Brussel
• Verification Date: May 2013