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

March 4, 2019 updated by: Ferring Pharmaceuticals

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

297

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Suresnes, France
        • Hospital FOCH (there may be other sites in this country)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 42 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Specialized fertility centers.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Menopur® HP-hMG
Treatment according to routine clinical practice.
Drug: Menotrophin
Other Names:
  • Menopur® HP-hMG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Spearman correlation coefficient between Menopur® 600 IU/mL dose and AMH serum levels
Time Frame: At baseline (inclusion)
At baseline (inclusion)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferring Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

January 31, 2018

Study Completion (Actual)

June 19, 2018

Study Registration Dates

First Submitted

October 14, 2016

First Submitted That Met QC Criteria

October 14, 2016

First Posted (Estimate)

October 17, 2016

Study Record Updates

Last Update Posted (Actual)

March 5, 2019

Last Update Submitted That Met QC Criteria

March 4, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 000237

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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