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NCT04876300 Clinical Trial

MEDAM (Menopur Retrospective Data prograM)

Infertility, Female Clinical Trial

— MEDAM  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04876300
Other study ID # 000376
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 4, 2021
Est. completion date November 30, 2021

Study information
Verified date November 2021
Source Ferring Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 11488
Est. completion date November 30, 2021
Est. primary completion date November 30, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 42 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No intervention
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.

Locations
Country Name City State
France Ferring investigational site Bondy
France Ferring investigational site Clamart
France Ferring investigational site Créteil
France Ferring investigational site Le Chesnay
France Ferring investigational site Lens
France Ferring investigational site Lyon
France Ferring investigational site Marseille
France Ferring investigational site Nice
France Ferring investigational site Rennes
France Ferring investigational site Rennes

Sponsors (1)
Lead Sponsor Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary Dose adjustment of Menotropin in IU At Day 1 of Menotropin stimulation up to Day 20 of Menotropin stimulation during 2009 to 2016
Secondary 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
Secondary 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
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