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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01732068
Other study ID # 2012/082
Secondary ID
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 short 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 short GnRH agonist protocol may result in acceptable pregnancy rates in poor ovarian responders fulfilling the "Bologna criteria"


Recruitment information / eligibility

Status Completed
Enrollment 51
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


Intervention

Drug:
Triptorelin
Triptorelin 0.1 mg/1 ml solution daily from day 1 or 2 of the cycle onwards
Corifollitropin alfa
Corifollitropin alfa 150µg (single dose) on day 2 or 3 of the cycle
hpHMG
300IU hMG daily from day 7 following Corifollitropin alfa until the day of ovulation triggering

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 embryo transfer Day of Embryo transfer No
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