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Completed

NCT Number: NCT04876300

MEDAM (Menopur Retrospective Data prograM)

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.

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Key information

Conditions

Infertility, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Urogenital Diseases

Age range

18 year–42 year

Sex eligibility

Female

Study type

Observational

Primary location

Ferring investigational site, Bondy, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

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.

Primary outcomes

  1. Cumulative live birth rate (cLBR)

    Time frame: 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 outcomes

  1. Initial dose of Menotropin treatment per IVF cycle (IU)

    Time frame: At Day 1 of Menotropin stimulation up to Day 20 of Menotropin stimulation during 2009 to 2016

  2. Total dose of Menotropin treatment per IVF cycle (IU)

    Time frame: At Day 1 of Menotropin stimulation up to Day 20 of Menotropin stimulation during 2009 to 2016

  3. Total days of Menotropin treatment (per IVF cycle)

    Time frame: 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.

  4. Dose adjustment of Menotropin in IU

    Time frame: At Day 1 of Menotropin stimulation up to Day 20 of Menotropin stimulation during 2009 to 2016

  5. Type of gonadotropin-releasing hormone (GnRH) protocols used for Luteinizing Hormone (LH) surge suppression (with in particular long and short agonist, and antagonist)

    Time frame: 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.

  6. Total days of LH surge suppression protocol

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: MEDAM

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 6, 2021
Registry last updated
Jan 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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