Clinical trial NCT04876300: MEDAM (Menopur Retrospective Data prograM)
Official title: Predicting the Cumulative Live Birth Rate Further Ovarian Stimulation by Highly Purified Human Menotropin HP-hMG. A Multicentre, Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility, Female
Keywords: Menotropin
HP-hMG
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2021-05-06
Enrollment: 11488
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult women, fitting the inclusion/exclusion criteria, who were prescribed Menotropin during 2009 to 2016 for COS in a treatment of infertility will be included in this study.

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.


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

Primary outcomes:
measure: Cumulative live birth rate (cLBR)
timeFrame: At delivery
Secondary outcomes:
measure: Initial dose of Menotropin treatment per IVF cycle (IU)
timeFrame: At Day 1 of Menotropin stimulation up to Day 20 of Menotropin stimulation during 2009 to 2016
measure: Total dose of Menotropin treatment per IVF cycle (IU)
timeFrame: At Day 1 of Menotropin stimulation up to Day 20 of Menotropin stimulation during 2009 to 2016
measure: Total days of Menotropin treatment (per IVF cycle)
timeFrame: Up to end of the ovarian stimulation treatment (up to 20 days) during 2009 to 2016
measure: Dose adjustment of Menotropin in IU
timeFrame: At Day 1 of Menotropin stimulation up to Day 20 of Menotropin stimulation during 2009 to 2016
measure: Type of gonadotropin-releasing hormone (GnRH) protocols used for Luteinizing Hormone (LH) surge suppression (with in particular long and short agonist, and antagonist)
timeFrame: At the day of the first GnRH administration during the ovarian stimulation treatment (up to 20 days) in 2009 to 2016
measure: Total days of LH surge suppression protocol
timeFrame: From Day 1 up to the last day of GnRH analogues administration during 2009 to 2016
Other outcomes:
Locations:
city: Bondy
country: France
facility: Ferring investigational site
city: Clamart
country: France
facility: Ferring investigational site
city: Créteil
country: France
facility: Ferring investigational site
city: Le Chesnay
country: France
facility: Ferring investigational site
city: Lens
country: France
facility: Ferring investigational site
city: Lyon
country: France
facility: Ferring investigational site
city: Marseille
country: France
facility: Ferring investigational site
city: Nice
country: France
facility: Ferring investigational site
city: Rennes
country: France
facility: Ferring investigational site
city: Rennes
country: France
facility: Ferring investigational site
Study officials:
affiliation: Ferring Pharmaceuticals
name: Global Clinical Compliance
role: STUDY_DIRECTOR
References: