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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nikolaos P. Polyzos, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
NCT01732068
First received: November 17, 2012
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Infertility
Poor Ovarian Response
 Drug: Triptorelin
Drug: Corifollitropin alfa
Drug: hpHMG
 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study for the Treatment of Poor Ovarian Responders With Corifollitropin Alfa Followed by hpHMG in a Short GnRH Agonist Protocol

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by Universitair Ziekenhuis Brussel:

Primary Outcome Measures:
  • Ongoing pregnancy rate [ Time Frame: 10 to 12 weeks of gestation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of oocytes retrieved [ Time Frame: Day of oocyte retrieval ] [ Designated as safety issue: No ]
  • Cycles with embryo transfer [ Time Frame: Day of Embryo transfer ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: July 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Corifollitropin alfa+hMG 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

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"

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01732068

Locations
Belgium
Centre for Reproductive Medicine UZ Brussel
Brussels, Belgium, 1090
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Investigators
Principal Investigator: Nikolaos P Polyzos, MD PhD UZ Brussel
  More Information

No publications provided

Responsible Party: Nikolaos P. Polyzos, Principal investigator, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT01732068     History of Changes
Other Study ID Numbers: 2012/082
Study First Received: November 17, 2012
Last Updated: May 7, 2013
Health Authority: Belgium: Institutional Review Board

Keywords provided by Universitair Ziekenhuis Brussel:
Poor ovarian response
Poor ovarian responders
Bologna criteria for poor ovarian response

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Triptorelin
Deslorelin
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
 Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013