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

Study Overview
=================
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.

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

Official Title
-----------------
Phase II Study for the Treatment of Poor Ovarian Responders With Corifollitropin Alfa Followed by hpHMG in a Short GnRH Agonist Protocol

Conditions
-----------------
Infertility, Poor Ovarian Response

Intervention / Treatment
-----------------
* Drug: Triptorelin
* Drug: Corifollitropin alfa
* Drug: hpHMG


Participation Criteria
=================
Eligibility 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: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Corifollitropin alfa+hMG<br> | Drug: Triptorelin<br>* Triptorelin 0.1 mg/1 ml solution daily from day 1 or 2 of the cycle onwards<br>Drug: Corifollitropin alfa<br>* Corifollitropin alfa 150μg (single dose) on day 2 or 3 of the cycle<br>Drug: hpHMG<br>* 300IU hMG daily from day 7 following Corifollitropin alfa until the day of ovulation triggering<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing pregnancy rate |  | 10 to 12 weeks of gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of oocytes retrieved |  | Day of oocyte retrieval | 
| Cycles with embryo transfer |  | Day of Embryo transfer | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Poor ovarian response, Poor ovarian responders, Bologna criteria for poor ovarian response