MEDAM (Menopur Retrospective Data prograM)

NCT ID: NCT04876300

Last Updated: 2022-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

11488 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-04

Study Completion Date

2021-11-30

Brief Summary

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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

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Conditions

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Infertility, Female

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Menotropin Cohort

No intervention

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ferring Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Compliance

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

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Ferring investigational site

Bondy, , France

Site Status

Ferring investigational site

Clamart, , France

Site Status

Ferring investigational site

Créteil, , France

Site Status

Ferring investigational site

Le Chesnay, , France

Site Status

Ferring investigational site

Lens, , France

Site Status

Ferring investigational site

Lyon, , France

Site Status

Ferring investigational site

Marseille, , France

Site Status

Ferring investigational site

Nice, , France

Site Status

Ferring investigational site

Rennes, , France

Site Status

Ferring investigational site

Rennes, , France

Site Status

Countries

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France

Other Identifiers

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000376

Identifier Type: -

Identifier Source: org_study_id

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