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Completed

NCT Number: NCT05310617

Parental Project and Premature Ovarian Insufficiency

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.

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Key information

Conditions

Primary Ovarian Insufficiency Adnexal Diseases Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Infertility Ovarian Diseases Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Service d'endocrinologie et médecine de la reproduction

Paris, 75013, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Survey

Other

Survey on the parental project and its realisation

Primary outcomes

  1. Realisation of parental project

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

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

Secondary outcomes

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

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

    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

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

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

    Evaluation of the number of children born after the diagnosis of POI

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

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

    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.)

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

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

    Evaluation of the characteristics of patients who were able to have a child after diagnosis:

    o age at diagnosis

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

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

    Evaluation of the characteristics of patients who were able to have a child after diagnosis:

    o AMH level

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

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

    Evaluation of the characteristics of patients who were able to have a child after diagnosis:

    o FSH level

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

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

    Evaluation of the characteristics of patients who were able to have a child after diagnosis:

    o presence of follicles on ultrasound

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

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

    Evaluation of the characteristics of patients who were able to have a child after diagnosis:

    o cause of POI

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

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

    Evaluation of the characteristics of patients who were able to have a child after diagnosis:

    o number of pregnancies prior to diagnosis

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

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

    Evaluation of the characteristics of patients who were able to have a child after diagnosis:

    o number of children before diagnosis

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

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

    Evaluation of the characteristics of patients who were able to have a child after diagnosis:

    o normal puberty

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

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

    Evaluation of the characteristics of patients who were able to have a child after diagnosis:

    o age at menarche

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: ParentIOP

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 5, 2022
Registry last updated
Oct 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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