Parental Project and Premature Ovarian Insufficiency (ParentIOP)

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.

Study Overview

• Status: Completed
• Conditions: Infertility; Primary Ovarian Insufficiency
• Intervention / Treatment: Other: Survey

Detailed Description

The investigators propose to study patients with POI who were hospitalized in the endocrinology and reproductive medicine department of the Pitié-Salpêtrière Hospital for the etiological assessment of ovarian failure and its consequences between December 31, 1982 and January 12, 2021. The investigators will only include patients who were admitted to the day hospital because we have a complete etiological workup and a complete history for them, which allows investigators to describe the population properly. The patients must be over 18 years old at the time of the survey in order to be able to evaluate the presence of a parental project only in adult patients.

Patients for whom there is no valid contact information in the computer file (postal address or valid email address or cell phone number) or whose last consultation was more than 2 years ago will be excluded. Patients with Turner syndrome will be excluded because they may have comorbidities, particularly cardiac, that contraindicate pregnancy. Patients with POI secondary to oncological treatments (gonadotoxic chemotherapy or pelvic radiotherapy) will also be excluded because of the uncertain prognosis and the contraindications to pregnancy in case of hormone-dependent tumors.

• Study Type: Observational
• Enrollment (Actual): 324

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Service d'endocrinologie et médecine de la reproduction

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine how and to what extent they have carried out their parental project	Evaluation if, after the diagnosis of POI, the parental project was realized through: spontaneous pregnancy or egg donation, simple stimulation or in vitro fertilization, embryo reception, or the adoption of a child 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 how many children on average these patients had after the diagnosis of POI.	Evaluation of the number of children born 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	Evaluation of the time between the diagnosis of POI and the birth of the first child after diagnosis according to the method (egg donation, spontaneous pregnancy, adoption, etc.)	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	Evaluation of the characteristics of patients who were able to have a child after diagnosis: o age at 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	Evaluation of the characteristics of patients who were able to have a child after diagnosis: o AMH level	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	Evaluation of the characteristics of patients who were able to have a child after diagnosis: o FSH level	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	Evaluation of the characteristics of patients who were able to have a child after diagnosis: o presence of follicles on ultrasound	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	Evaluation of the characteristics of patients who were able to have a child after diagnosis: o cause 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
Survey. Describe the characteristics of patients who were able to have a child after diagnosis	Evaluation of the characteristics of patients who were able to have a child after diagnosis: o number of pregnancies prior to 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	Evaluation of the characteristics of patients who were able to have a child after diagnosis: o number of children before 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	Evaluation of the characteristics of patients who were able to have a child after diagnosis: o normal puberty	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	Evaluation of the characteristics of patients who were able to have a child after diagnosis: o age at menarche	data from patients with a diagnosis between 31/12/1982 and 12/01/2021 and whose opposition to the study is not expressed

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Philippe Touraine, Pr, APHP

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2022
• Primary Completion (Actual): June 20, 2022
• Study Completion (Actual): June 20, 2022

Study Registration Dates

• First Submitted: March 21, 2022
• First Submitted That Met QC Criteria: April 4, 2022
• First Posted (Actual): April 5, 2022

Study Record Updates

• Last Update Posted (Actual): October 4, 2022
• Last Update Submitted That Met QC Criteria: October 3, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: oocyte donation; adoption; spontaneous pregnancy; parental project
• Additional Relevant MeSH Terms: Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Infertility; Primary Ovarian Insufficiency; Menopause, Premature
• Other Study ID Numbers: APHP220208

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No