NCT02935335

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
297

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 17, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2018

Completed
Last Updated

March 5, 2019

Status Verified

March 1, 2019

Enrollment Period

1.3 years

First QC Date

October 14, 2016

Last Update Submit

March 4, 2019

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Spearman correlation coefficient between Menopur® 600 IU/mL dose and AMH serum levels

    At baseline (inclusion)

Study Arms (1)

Menopur® HP-hMG

Treatment according to routine clinical practice.

Drug: Menotrophin

Interventions

MenotrophinDRUG
Also known as: Menopur® HP-hMG
Menopur® HP-hMG

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Specialized fertility centers.

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital FOCH (there may be other sites in this country)

Suresnes, France

Location

MeSH Terms

Conditions

Infertility

Interventions

Menotropins

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropins, PituitaryGonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPituitary Hormones, AnteriorPituitary HormonesPeptidesAmino Acids, Peptides, and ProteinsBiological ProductsComplex Mixtures

Study Officials

  • Clinical Development Support

    Ferring Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2016

First Posted

October 17, 2016

Study Start

October 1, 2016

Primary Completion

January 31, 2018

Study Completion

June 19, 2018

Last Updated

March 5, 2019

Record last verified: 2019-03

Locations

FR(1)