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

Infertility Clinical Trial

— AME  

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02935335
• Other study ID #: 000237
• Status: Completed
• Start date: October 2016
• Est. completion date: June 19, 2018

Study information

• Verified date: March 2019
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 297
• Est. completion date: June 19, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Menotrophin

Locations

Country	Name	City	State
France	Hospital FOCH (there may be other sites in this country)	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spearman correlation coefficient between Menopur® 600 IU/mL dose and AMH serum levels		At baseline (inclusion)