NCT04876300

Brief Summary

French, non-interventional, retrospective, multicentric analysis of patients who have undergone a controlled ovarian stimulation (COS) for in-vitro fertilization (IVF)/ intracytoplasmic sperm injection (ICSI). The main objective is to determine the cumulative live birth rate with highly purified menotropin (HP-hMG) which is defined as the occurrence of live birth per started COS, further to transfer of fresh and frozen embryos generated from the same COS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11,488

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

10 active sites

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

First Submitted

Initial submission to the registry

May 3, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 6, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

November 4, 2021

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

January 25, 2022

Status Verified

November 1, 2021

Enrollment Period

26 days

First QC Date

May 3, 2021

Last Update Submit

January 24, 2022

Conditions

Infertility, Female

Keywords

MenotropinHP-hMG

Outcome Measures

Primary Outcomes (1)

  • Cumulative live birth rate (cLBR)

    Defined as the occurence of live birth per started COS, further to transfer of fresh and frozen embryos generated from the same COS.

    At delivery

Secondary Outcomes (6)

  • Initial dose of Menotropin treatment per IVF cycle (IU)

    At Day 1 of Menotropin stimulation up to Day 20 of Menotropin stimulation during 2009 to 2016

  • Total dose of Menotropin treatment per IVF cycle (IU)

    At Day 1 of Menotropin stimulation up to Day 20 of Menotropin stimulation during 2009 to 2016

  • Total days of Menotropin treatment (per IVF cycle)

    Up to end of the ovarian stimulation treatment (up to 20 days) during 2009 to 2016

  • Dose adjustment of Menotropin in IU

    At Day 1 of Menotropin stimulation up to Day 20 of Menotropin stimulation during 2009 to 2016

  • Type of gonadotropin-releasing hormone (GnRH) protocols used for Luteinizing Hormone (LH) surge suppression (with in particular long and short agonist, and antagonist)

    At the day of the first GnRH administration during the ovarian stimulation treatment (up to 20 days) in 2009 to 2016

  • +1 more secondary outcomes

Study Arms (1)

Menotropin Cohort

Other: No intervention

Interventions

No interventionOTHER

All directions for medication usage were solely at the discretion of the investigator in accordance with their usual routine clinical practice and are assumed to be consistent with the national prescribing information of the medicinal product in the country in which the study will take place.

Menotropin Cohort

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAdult females who underwent COS treatment with Menotropin during 2009 to 2016.
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adult women, fitting the inclusion/exclusion criteria, who were prescribed Menotropin during 2009 to 2016 for COS in a treatment of infertility will be included in this study.

You may qualify if:

  • \- Patient undergoing a COS with HP-hMG for IVF/ICSI cycle from a French data registry between 2009 to 2016

You may not qualify if:

  • Ovulation inductions
  • Intra-uterine inseminations
  • Fertility preservations
  • Oocyte donations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Ferring investigational site

Bondy, 93140, France

Location

Ferring investigational site

Clamart, 92140, France

Location

Ferring investigational site

Créteil, 94010, France

Location

Ferring investigational site

Le Chesnay, 78150, France

Location

Ferring investigational site

Lens, 62190, France

Location

Ferring investigational site

Lyon, 69002, France

Location

Ferring investigational site

Marseille, 13008, France

Location

Ferring investigational site

Nice, 06100, France

Location

Ferring investigational site

Rennes, 35000, France

Location

Ferring investigational site

Rennes, 35033, France

Location

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Study Officials

  • Global Clinical Compliance

    Ferring Pharmaceuticals

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

May 3, 2021

First Posted

May 6, 2021

Study Start

November 4, 2021

Primary Completion

November 30, 2021

Study Completion

November 30, 2021

Last Updated

January 25, 2022

Record last verified: 2021-11

Locations

FR(10)