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Completed

NCT Number: NCT02935335

A Study to Measure Relationship Between Antimüllerian Hormone and Initial Dose of Menopur®

AME is a non-interventional, prospective, longitudinal and multicenter study. This study aims to measure the relationship between antimüllerian hormone serum level (AMH), as measured by a fully automated assay and the initial dose of Menopur® HP-hMG 600 IU/mL prescribed for infertile women undergoing their first IVF/ICSI cycle in the current practice.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–42 year

Sex eligibility

Female

Study type

Observational

Primary location

Hospital FOCH (there may be other sites in this country)

Suresnes, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women aged between [18-42] years.
  • Both ovaries present.
  • Regular menstrual cycles presumed to be ovulatory.
  • Primary or secondary infertility of any origin for more than 12 months.
  • Patient with at least one result of antimüllerian hormone (AMH) measured by a fully automated assay available before inclusion, and performed in the past 12 months before inclusion.
  • Candidates eligible to a first IVF/ICSI cycle and for whom Menopur® HP-hMG 600 IU/mL has been prescribed.
  • Having received oral and written information on the study, without any objections for the use of his/her anonymized data, and having signed a written Informed Consent Form.

Exclusion criteria

  • Major uterine or ovarian morphological abnormalities or past ovarian surgery.
  • Endometriosis stage III/IV.
  • Polycystic ovarian syndrome.
  • Major endocrine or metabolic abnormalities without treatment.
  • Patient included in an interventional study assessing treatment for infertility.

Treatment and study plan

Menotrophin

Drug

Other names: Menopur® HP-hMG

Primary outcomes

  1. Spearman correlation coefficient between Menopur® 600 IU/mL dose and AMH serum levels

    Time frame: At baseline (inclusion)

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

Relationship Between antimüllerian Hormone Measured by a Fully Automated Assay and the Initial Dose of HP-hMG (Menopur®) Prescribed for Infertile Women Undergoing Their First IVF/ICSI Cycle.

Acronym: AME

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 17, 2016
Registry last updated
Mar 5, 2019

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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