MEDAM (Menopur Retrospective Data prograM)

Study Overview
=================
Brief Summary
-----------------
French, non-interventional, retrospective, multicentric analysis of patients who have undergone a controlled ovarian stimulation (COS) for in-vitro fertilization (IVF)/ intracytoplasmic sperm injection (ICSI). The main objective is to determine the cumulative live birth rate with highly purified menotropin (HP-hMG) which is defined as the occurrence of live birth per started COS, further to transfer of fresh and frozen embryos generated from the same COS.

Official Title
-----------------
Predicting the Cumulative Live Birth Rate Further Ovarian Stimulation by Highly Purified Human Menotropin HP-hMG. A Multicentre, Retrospective Study

Conditions
-----------------
Infertility, Female

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patient undergoing a COS with HP-hMG for IVF/ICSI cycle from a French data registry between 2009 to 2016 Exclusion Criteria: Ovulation inductions Intra-uterine inseminations Fertility preservations Oocyte donations

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 42 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Menotropin Cohort<br> | Other: No intervention<br>* All directions for medication usage were solely at the discretion of the investigator in accordance with their usual routine clinical practice and are assumed to be consistent with the national prescribing information of the medicinal product in the country in which the study will take place.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative live birth rate (cLBR) | Defined as the occurence of live birth per started COS, further to transfer of fresh and frozen embryos generated from the same COS. | At delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initial dose of Menotropin treatment per IVF cycle (IU) |  | At Day 1 of Menotropin stimulation up to Day 20 of Menotropin stimulation during 2009 to 2016 | 
| Total dose of Menotropin treatment per IVF cycle (IU) |  | At Day 1 of Menotropin stimulation up to Day 20 of Menotropin stimulation during 2009 to 2016 | 
| Total days of Menotropin treatment (per IVF cycle) | Duration of treatment (in days) with Menotropin of patients will be reported. | Up to end of the ovarian stimulation treatment (up to 20 days) during 2009 to 2016 | 
| Dose adjustment of Menotropin in IU |  | At Day 1 of Menotropin stimulation up to Day 20 of Menotropin stimulation during 2009 to 2016 | 
| Type of gonadotropin-releasing hormone (GnRH) protocols used for Luteinizing Hormone (LH) surge suppression (with in particular long and short agonist, and antagonist) | Gonadotropin-releasing hormone protocols with in particular long and short agonist, and antagonist. | At the day of the first GnRH administration during the ovarian stimulation treatment (up to 20 days) in 2009 to 2016 | 
| Total days of LH surge suppression protocol | Gonadotropin-releasing hormone protocols with in particular long and short agonist, and antagonist. | From Day 1 up to the last day of GnRH analogues administration during 2009 to 2016 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Menotropin, HP-hMG