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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01732094
• Other study ID #: 2012/084
• Status: Completed
• Phase: Phase 2
• First received: November 17, 2012
• Last updated: May 7, 2013
• Start date: July 2012
• Est. completion date: May 2013

Study information

• Verified date: May 2013
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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"

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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:

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility
• Poor Ovarian Response

Intervention

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

Locations

Country	Name	City	State
Belgium	Centre for Reproductive Medicine UZ Brussel	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ongoing pregnancy rate		10 to 12 weeks of gestation	No
Secondary	Number of oocytes retrieved		Day of oocyte retrieval	No
Secondary	Cycles with oocyte retrieval		Day of oocyte retrieval	No
Secondary	Cycles with embryo transfer		Day of Embryo transfer	No