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

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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02935335
Acronym
AME
Enrollment
297
Registered
2016-10-17
Start date
2016-10-31
Completion date
2018-06-19
Last updated
2019-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

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.

Interventions

Sponsors

Ferring Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Spearman correlation coefficient between Menopur® 600 IU/mL dose and AMH serum levelsAt baseline (inclusion)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026