MEDAM (Menopur Retrospective Data prograM)

Completed

• Conditions: Infertility, Female
• Interventions: Other: No intervention

• Registration Number: NCT04876300
• Lead Sponsor: Ferring Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-03
• Study First Submitted QC: 2021-05-03
• Study First Posted: 2021-05-06
• Status Verified: 2021-11
• Study Start: 2021-11-04
• Primary Completion: 2021-11-30
• Study Completion: 2021-11-30
• Last Update Submitted: 2022-01-24
• Last Update Posted: 2022-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 11488

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Menotropin Cohort	No intervention	-

Primary Outcome Measures

Name	Time	Method
Cumulative live birth rate (cLBR)	At delivery	Defined as the occurence of live birth per started COS, further to transfer of fresh and frozen embryos generated from the same COS.

Secondary Outcome Measures

Name	Time	Method
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
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)	At the day of the first GnRH administration during the ovarian stimulation treatment (up to 20 days) in 2009 to 2016	Gonadotropin-releasing hormone protocols with in particular long and short agonist, and antagonist.
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)	Up to end of the ovarian stimulation treatment (up to 20 days) during 2009 to 2016	Duration of treatment (in days) with Menotropin of patients will be reported.
Total days of LH surge suppression protocol	From Day 1 up to the last day of GnRH analogues administration during 2009 to 2016	Gonadotropin-releasing hormone protocols with in particular long and short agonist, and antagonist.

Trial Locations

Locations (1)

Ferring investigational site; 🇫🇷 Rennes, France