NCT05310617

Brief Summary

One of the main repercussions of POI is infertility. When the diagnosis of POI is announced, the question of fertility is addressed and the patient is often directed towards egg donation or adoption when she has a parental project. However, there are cases of spontaneous pregnancies after diagnosis. This study was conducted to determine the proportion of patients with POI who were able to realize a parental project after diagnosis in the long term and by what means.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
324

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 5, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

June 20, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2022

Completed
Last Updated

October 4, 2022

Status Verified

September 1, 2022

Enrollment Period

Same day

First QC Date

March 21, 2022

Last Update Submit

October 3, 2022

Conditions

Keywords

spontaneous pregnancyadoptionoocyte donationparental project

Outcome Measures

Primary Outcomes (1)

  • Realisation of parental project

    Determine proportion of patient who realised a parental project after the diagnosis of POI

    data from patients with a diagnosis between 31/12/1982 and 12/01/2021 and whose opposition to the study is not expressed

Secondary Outcomes (12)

  • Determine how and to what extent they have carried out their parental project

    data from patients with a diagnosis between 31/12/1982 and 12/01/2021 and whose opposition to the study is not expressed

  • determine how many children on average these patients had after the diagnosis of POI.

    data from patients with a diagnosis between 31/12/1982 and 12/01/2021 and whose opposition to the study is not expressed

  • determine the delay between the diagnosis of POI and the birth of the first child after the diagnosis according to the method

    data from patients with a diagnosis between 31/12/1982 and 12/01/2021 and whose opposition to the study is not expressed

  • Survey. Describe the characteristics of patients who were able to have a child after diagnosis

    data from patients with a diagnosis between 31/12/1982 and 12/01/2021 and whose opposition to the study is not expressed

  • Survey. Describe the characteristics of patients who were able to have a child after diagnosis

    data from patients with a diagnosis between 31/12/1982 and 12/01/2021 and whose opposition to the study is not expressed

  • +7 more secondary outcomes

Interventions

SurveyOTHER

Survey on the parental project and its realisation

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with POI who were hospitalized in a day hospital (HDJ) in the endocrinology and reproductive medicine department of the Pitié-Salpêtrière hospital for the etiological assessment of ovarian insufficiency and its repercussions between 31/12/1982 and 12/01/2021

You may qualify if:

  • Patients at least 18 years old at the time of the survey
  • Patients with a diagnosis of PIO according to the current definition: cycle disturbances of more than 4 months and FSH \> 25 on 2 measurements one month apart
  • Patients having been hospitalized in day hospital (HDJ) in the endocrinology and reproductive medicine department of the Pitié-Salpêtrière hospital for the etiological assessment of ovarian insufficiency and its repercussions between December 31, 1982 and January 12, 2021
  • Valid contact information available: address, cell phone, e-mail
  • Patients who have been informed and do not object to participate in the study

You may not qualify if:

  • Turner syndrome
  • POI secondary to oncology treatments (chemotherapy, pelvic radiotherapy)
  • Opposition to participating in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'endocrinologie et médecine de la reproduction

Paris, 75013, France

Location

MeSH Terms

Conditions

Primary Ovarian InsufficiencyInfertility

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Philippe Touraine, Pr

    APHP

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 21, 2022

First Posted

April 5, 2022

Study Start

June 20, 2022

Primary Completion

June 20, 2022

Study Completion

June 20, 2022

Last Updated

October 4, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations