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

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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

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.

Condition or disease Intervention/treatment Phase
Infertility Poor Ovarian Response Drug: Triptorelin Drug: Corifollitropin alfa Drug: hpHMG Phase 2

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  (Clinical Trial)
Actual Enrollment : 51 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Ongoing pregnancy rate [ Time Frame: 10 to 12 weeks of gestation ]

Secondary Outcome Measures :
  1. Number of oocytes retrieved [ Time Frame: Day of oocyte retrieval ]
  2. Cycles with embryo transfer [ Time Frame: Day of Embryo transfer ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Universitair Ziekenhuis Brussel

Responsible Party: Nikolaos P. Polyzos, Principal investigator, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT01732068     History of Changes
Other Study ID Numbers: 2012/082
First Posted: November 22, 2012    Key Record Dates
Last Update Posted: May 9, 2013
Last Verified: May 2013

Keywords provided by Nikolaos P. Polyzos, 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
Deslorelin
Triptorelin Pamoate
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents