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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01732094

Enrollment

Registered

2012-11-22

Start date

2012-07-31

Completion date

2013-05-31

Last updated

2013-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Poor Ovarian Response

Keywords

Poor ovarian response, Poor ovarian responders, Bologna criteria for poor ovarian response

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.

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

Interventions

DRUGTriptorelin

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

DRUGCorifollitropin alfa 150μg

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

DRUGhpHMG

hpHMG 300IU daily from day 7 following Corifollitropin alfa onwards

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

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: 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

Design outcomes

Primary

Measure	Time frame
Ongoing pregnancy rate	10 to 12 weeks of gestation

Secondary

Measure	Time frame
Number of oocytes retrieved	Day of oocyte retrieval
Cycles with oocyte retrieval	Day of oocyte retrieval
Cycles with embryo transfer	Day of Embryo transfer

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026