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

Ferring

Status: Completed

Conditions: Infertility

Treatments: Drug: Menotrophin

Study type: Observational

Funder types: Industry

Identifiers

NCT02935335

000237

Details and patient eligibility

About

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.

Enrollment: 297 patients

Sex: Female

Ages: 18 to 42 years old

Volunteers: No Healthy Volunteers

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.

Trial design

297 participants in 1 patient group

Menopur® HP-hMG

Description:

Treatment according to routine clinical practice.

Treatment:

Drug: Menotrophin