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

Completed

• Conditions: Infertility
• Interventions: Drug: Menotrophin

• Registration Number: NCT02935335
• Lead Sponsor: Ferring Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-14
• Study First Submitted QC: 2016-10-14
• Study First Posted: 2016-10-17
• Primary Completion: 2018-01-31
• Study Completion: 2018-06-19
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-04
• Last Update Posted: 2019-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 297

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Menopur® HP-hMG	Menotrophin	Treatment according to routine clinical practice.

Primary Outcome Measures

Name	Time	Method
Spearman correlation coefficient between Menopur® 600 IU/mL dose and AMH serum levels	At baseline (inclusion)

Trial Locations

Locations (1)

Hospital FOCH (there may be other sites in this country); 🇫🇷 Suresnes, France