Modified Natural Cycle Offers a Chance of Pregnancy in Patients With Poor Response and High Basal FSH

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness of a modified natural cycle in patients with previous poor response to infertility drugs and high basal FSH, prior to proceeding to oocyte donation or abandoning fertility treatment.

Detailed Description
-----------------
Poor responders are a diverse group of IVF patients who fail to respond to IVF drugs. In these patients pregnancy rates remain disappointingly low and usually oocyte donation is their only viable option. The need for lengthy ovarian stimulation regimes can be avoided by performing IVF during a natural menstrual cycle. However, the main problem with a natural cycle is that successful IVF outcome can be compromised by a premature LH surge. This problem can be solved by the administration of GnRH antagonists that suppress endogenous gonadotropin levels, comprising a modified natural cycle (MNC). Previous studies have shown that MNC offers no realistic chances of pregnancy prior to oocyte donation. In this study we will re-assess this view by showing that MNC offers some, albeit small, chances of positive IVF outcome in patients with known previous poor response prior to oocyte donation.

Official Title
-----------------
Successful Application of Modified Natural Cycle in Poor Responders With High Basal FSH Prior to Oocyte Donation

Conditions
-----------------
Infertility, Premature Ovarian Failure

Intervention / Treatment
-----------------
* Drug: recombinant FSH (Puregon, Organon, The Netherlands)
* Drug: GnRH antag: Ganirelix (Orgalutran, Organon, The Netherlands)
* Drug: hCG (Pregnyl, Organon, The Netherlands)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Regular menstrual cycle (21-35 days) Basal FSH>12 IU/ml One or more failed IVF attempts (<3 oocyte retrieved) Exclusion Criteria: PCOS Normal responders

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: recombinant FSH (Puregon, Organon, The Netherlands)|nan|
|Drug: GnRH antag: Ganirelix (Orgalutran, Organon, The Netherlands)|nan|
|Drug: hCG (Pregnyl, Organon, The Netherlands)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth per started cycle |  | live birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical pregnancy per started cycle |  | positive hCG test 14 days post oocyte retrieval | 
| Clinical pregnancy per started cycle |  | presence of fetal sac and heart beat at 7 weeks of gestation | 
| Cycle cancellation rates |  | cycles not reaching oocyte retrieval | 
| Ongoing pregnancy rates per started cycle |  | presence of fetal sac and heart beat at 12 weeks of gestation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GnRH antagonist, Poor responders, Oocyte donation, Modified natural cycle