Primary Ovarian InsufficiencyParentIOPNCT05310617
Parental Project and Premature Ovarian Insufficiency
An observational study of Primary Ovarian Insufficiency and Infertility, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Primary Ovarian Insufficiency, Infertility
- What is being tested?
- Survey
- How many people
- 324 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jun 2022to 20 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Turner syndrome
- POI secondary to oncology treatments (chemotherapy, pelvic radiotherapy)
- Opposition to participating in the study
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'endocrinologie et médecine de la reproduction
Paris, 75013
About this study
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.
Read the 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.
- Conditions
- Primary Ovarian Insufficiency, Infertility
- Being tested
- Survey
- Keywords
- spontaneous pregnancy, adoption, oocyte donation, parental project
- Medical subject headings
- Primary Ovarian Insufficiency, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Survey on the parental project and its realisation
What is being measured
The primary outcome is the main question the study is designed to answer.
Realisation of parental project
Determine proportion of patient who realised a parental project after the diagnosis of POI
Measured: 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
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
Measured: 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
Measured: 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.)
Measured: 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:
- age at diagnosis
Measured: 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:
- AMH level
Measured: 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:
- FSH level
Measured: 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:
- presence of follicles on ultrasound
Measured: 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:
- cause of POI
Measured: 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:
- number of pregnancies prior to diagnosis
Measured: 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:
- number of children before diagnosis
Measured: 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:
- normal puberty
Measured: 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:
- age at menarche
Measured: data from patients with a diagnosis between 31/12/1982 and 12/01/2021 and whose opposition to the study is not expressed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start20 Jun 2022
- Primary completion20 Jun 2022
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Ovarian InsufficiencyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Touraine, Pr, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05310617
- Sponsor's protocol ID
- APHP220208
- Acronym
- ParentIOP
- Status last verified
- Sep 2022
- First submitted
- 21 Mar 2022
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parental Project and Premature Ovarian Insufficiency
- ClinicalTrials.gov ID
- NCT05310617
- Acronym / sponsor ID
- ParentIOP / APHP220208
- Conditions
- Primary Ovarian Insufficiency, Infertility
- Keywords
- spontaneous pregnancy, adoption, oocyte donation, parental project
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 5 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Turner syndrome
- POI secondary to oncology treatments (chemotherapy, pelvic radiotherapy)
- Opposition to participating in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveySurvey on the parental project and its realisation | Other | – |
Primary outcome
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
12 secondary outcomes
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
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
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
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
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Touraine, Pr principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Ovarian Insufficiency and Infertility, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2022.