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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

297 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-06-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Infertility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Menopur® HP-hMG

Treatment according to routine clinical practice.

Menotrophin

Intervention Type DRUG

Interventions

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Menotrophin

Intervention Type DRUG

Other Intervention Names

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Menopur® HP-hMG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No