Corifollitropin Alfa Followed by hpHMG in a Long GnRH Agonist Protocol for the Treatment of Poor Ovarian Responders

Sponsor

Universitair Ziekenhuis Brussel (Other)

Overall Status

Completed

CT.gov ID

NCT01732094

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

5.7

Patients Per Site Per Month

Study Details

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 long GnRH agonist protocol.

Condition or Disease	Intervention/Treatment	Phase
Infertility Poor Ovarian Response	Drug: Triptorelin Drug: Corifollitropin alfa 150μg 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 long GnRH agonist protocol may result in acceptable pregnancy rates in poor ovarian responders fulfilling the "Bologna criteria"

Study Design

Study Type:

Interventional

Actual Enrollment :

57 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase II Study of Corifollitropin Alfa Followed by hpHMG in a Long GnRH Agonist Protocol for the Treatment of Poor Ovarian Responders

Study Start Date :

Jul 1, 2012

Actual Primary Completion Date :

May 1, 2013

Actual Study Completion Date :

May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Corifollitropin Alfa + hMG	Drug: Triptorelin Triptorelin 0.1 mg/1 ml solution daily from day 21 of the cycle onwards Drug: Corifollitropin alfa 150μg Corifollitropin alfa 150μg (single dose) 2 or 3 weeks after initiation of triptorelin Drug: hpHMG hpHMG 300IU daily from day 7 following Corifollitropin alfa onwards

Arm

Intervention/Treatment

Experimental: Corifollitropin Alfa + hMG

Drug: Triptorelin

Triptorelin 0.1 mg/1 ml solution daily from day 21 of the cycle onwards

Drug: Corifollitropin alfa 150μg

Corifollitropin alfa 150μg (single dose) 2 or 3 weeks after initiation of triptorelin

Drug: hpHMG

hpHMG 300IU daily from day 7 following Corifollitropin alfa onwards

Outcome Measures

Primary Outcome Measures

Ongoing pregnancy rate [10 to 12 weeks of gestation]

Secondary Outcome Measures

Number of oocytes retrieved [Day of oocyte retrieval]
Cycles with oocyte retrieval [Day of oocyte retrieval]
Cycles with embryo transfer [Day of Embryo transfer]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients should fulfill the "Bologna criteria" for poor ovarian response

At least two of the following three features must be present:

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nikolaos P. Polyzos, Principal Investigator, Universitair Ziekenhuis Brussel

ClinicalTrials.gov Identifier:

NCT01732094

Other Study ID Numbers:

2012/084

First Posted:

Nov 22, 2012

Last Update Posted:

May 9, 2013

Last Verified:

May 1, 2013

Keywords provided by Nikolaos P. Polyzos, Principal Investigator, Universitair Ziekenhuis Brussel

Poor ovarian response

Poor ovarian responders

Bologna criteria for poor ovarian response

Additional relevant MeSH terms:

Infertility

Triptorelin Pamoate

Study Results

No Results Posted as of May 9, 2013