Premature Ovarian Failure (POF)DESIOPNCT04881695
Evaluation of Child Desire in Young Women With Premature Ovarian Failure
An observational study of Premature Ovarian Failure (POF), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Premature ovarian failure (POF) is a rare condition, affecting 1 in 10,000 women before age 20 and 1 in 1,000 women before age 30. The two main causes of POF are congenital and acquired. Read more about this study
- Who is it for?
- Ages 18 to 26 years, women only
- Conditions the study is for
- Premature Ovarian Failure (POF)
- What is being tested?
- Questionary patients
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 10 May 2021to 30 Jan 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 to 26 years
- Women only
- No healthy volunteers
- Adult
Study population: Women aged 18 to 26 with congenital POF (linked to Turner Syndrome or to another determined or undetermined genetic cause) or acquired (post-treatment), having consulted at least once at the bicetre hospital.
Who may be able to join
- Women aged 18 to 26
- Diagnosed with POF according to the following criteria:
- Absence of pubertal development or primary or secondary amenorrhea for more than 4 months Follicle Stimulating Hormone (FSH) rate> 40 mL U /L, on at least two separate samples taken at least one month apart Low estradiol level <40 pg / mL
- POF of congenital (Turner syndrome or other genetic cause) or acquired (post-therapeutic) origin
- Who consulted in the Adolescent and Young Adult Gynecology Unit at bicetre Hospital between 2014 and 2021
Who cannot join
- Minor patient or over 26 years old
- Inability to complete the questionnaire
- Lack of social security coverage
- Patient under state medical aid
- Patient under guardianship or curators or under legal protection
- POF not confirmed (for patients only)
- Condition impacting fertility or having already been pregnant or pregnant at the time of the study (for controls)
Trial locations and contacts
1 site in 1 country.
Iris GUILLAUME, Resident contact
France1 site
Hospital Bicetre
Le Kremlin-Bicêtre, 94275
Lise DURANTEAU, Doctor, 00331 45 21 78 41, lise.duranteau@aphp.fr
About this study
Premature ovarian failure (POF) is a rare condition, affecting 1 in 10,000 women before age 20 and 1 in 1,000 women before age 30. The two main causes of POF are congenital and acquired.
Patients with POF who carry out the desire to have a child turn to medically assisted reproduction through oocyte donation or to adoption.
The main endpoint of this study is to compare the desire to have children among women with premature ovarian failure (POF) aged 18 to 26 years vs. controls of the same age (stratified by age) without major menstruation disorder.
Read the detailed description
Premature ovarian failure (POF) is a rare condition, affecting 1 in 10,000 women before age 20 and 1 in 1,000 women before age 30. The two main causes of POF are congenital and acquired.
Patients with POF who carry out the desire to have a child turn to medically assisted reproduction through oocyte donation or to adoption.
The main endpoint of this study is to compare the desire to have children among women with premature ovarian failure (POF) aged 18 to 26 years vs. controls of the same age (stratified by age) without major menstruation disorder. The primary endpoint is the percentage of women with POF reporting a desire to have a child (yes / no) vs. controls of the same age with normal gonadal function/ The answers will be collected on two online questionnaires.
The secondary endpoints are:
- Look for a difference in the desire for a child according to the age at the diagnosis of POF, the cause of POF, the intake of hormone replacement therapy and the age of the patients at the time of the study.
- Assess the sexual life of women in POF.
- Assess the psychological state of women with POF-related infertility and help identify those with symptoms of anxiety or depression. He will be assessed by the Hospital Anxiety and Depression Questionnaire to help identify those with symptoms of anxiety or depression.
The women will be contacted by email and will receive a newsletter. The controls will be recruited from patients who have visited at least once at bicetre Hospital and who do not have a condition that could impair fertility. They must not have been pregnant or must not be pregnant at the time of the study. The email will contain a questionnaire.
We estimate that 120 patients will meet the inclusion and non-inclusion criteria among the patients on the Unit.
Considering that 80 patients (2/3) will answer the questionnaires, we will be able to include 80 patients and 80 controls in our study.
The proportion of women wishing to have children, in the general population, in the study age group is estimated at 90%. Including 160 participants will allow us to show a 20% difference in the proportion of desire to have children in patients with POF, with a power of 90%, an alpha risk of 5% and a bilateral formulation.
- Conditions
- Premature Ovarian Failure (POF)
- Being tested
- Questionary patients, Questionary controls
- Keywords
- Desire children, infertility, medical assisted procreation
- 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.
Questionary patientsOther
The patients will answer 1 questionnaire consisting of 5 parts :
- General (demographic information)
- Desire for a child
- Hospital Anxiety and Depression scale
- Sexual life
- Additional questions regarding medical care
Questionary controlsOther
Witnesses will complete 1 survey containing 4 parts:
- General (demographic information)
- Desire to have a child
- Hospital Anxiety and Depression scale
- Sexual life
| Study group | Role | What they receive |
|---|---|---|
| Patients | Women aged 18-26 years with congenital (Turner syndrome or other determined or undetermined genetic cause) or acquired (post-therapeutic) Receives: Other: Questionary patients | |
| Controls | Women aged 18-26 years who do not have a condition that compromises their fertility Receives: Other: Questionary controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of POI patients expressing a desire for a child (yes/no) compared to controls of the same age with no fertility compromising condition,
To compare the desire for children of patients with premature ovarian failure (POI) aged 18-26 years with controls of the same age group (inclusion stratified by age in 2-year strata) with no fertility compromising condition.
Measured: 3 months
Secondary outcomes (2)
Assess the sexual life of women with POF
Assess the sexual life of women in POF by answering a questionary compared to the answers of controls.
- The score of patients will be compared to the score of controls.
Measured: 3 months
Assess the psychological state of women with POF-related infertility and help identify those with symptoms of anxiety or depression.
Assess by the Hospital Anxiety and Depression questionnaire to help identify those with symptoms of anxiety or depression.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start10 May 2021 (estimated)
- Primary completion30 Jan 2022 (estimated)
- Study completion30 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ovarian Failure (POF)Studies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lise DURANTEAU, Doctor, Principal investigator, Hospital Bicetre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04881695
- Sponsor's protocol ID
- APHP210157
- Other IDs
- 2020-A02741-38
- Acronym
- DESIOP
- Status last verified
- Apr 2021
- First submitted
- 29 Apr 2021
- Last updated
- 11 May 2021
- 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 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Child Desire in Young Women With Premature Ovarian Failure
- ClinicalTrials.gov ID
- NCT04881695
- Acronym / sponsor ID
- DESIOP / APHP210157
- Conditions
- Premature Ovarian Failure (POF)
- Keywords
- Desire children, infertility, medical assisted procreation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 10 May 2021 (estimated)
- Primary completion
- 30 Jan 2022 (estimated)
- Study completion
- 30 Jan 2022 (estimated)
- First posted
- 11 May 2021 (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.
Premature ovarian failure (POF) is a rare condition, affecting 1 in 10,000 women before age 20 and 1 in 1,000 women before age 30. The two main causes of POF are congenital and acquired.
Patients with POF who carry out the desire to have a child turn to medically assisted reproduction through oocyte donation or to adoption.
The main endpoint of this study is to compare the desire to have children among women with premature ovarian failure (POF) aged 18 to 26 years vs. controls of the same age (stratified by age) without major menstruation disorder.
Detailed description
Premature ovarian failure (POF) is a rare condition, affecting 1 in 10,000 women before age 20 and 1 in 1,000 women before age 30. The two main causes of POF are congenital and acquired.
Patients with POF who carry out the desire to have a child turn to medically assisted reproduction through oocyte donation or to adoption.
The main endpoint of this study is to compare the desire to have children among women with premature ovarian failure (POF) aged 18 to 26 years vs. controls of the same age (stratified by age) without major menstruation disorder. The primary endpoint is the percentage of women with POF reporting a desire to have a child (yes / no) vs. controls of the same age with normal gonadal function/ The answers will be collected on two online questionnaires.
The secondary endpoints are:
- Look for a difference in the desire for a child according to the age at the diagnosis of POF, the cause of POF, the intake of hormone replacement therapy and the age of the patients at the time of the study.
- Assess the sexual life of women in POF.
- Assess the psychological state of women with POF-related infertility and help identify those with symptoms of anxiety or depression. He will be assessed by the Hospital Anxiety and Depression Questionnaire to help identify those with symptoms of anxiety or depression.
The women will be contacted by email and will receive a newsletter. The controls will be recruited from patients who have visited at least once at bicetre Hospital and who do not have a condition that could impair fertility. They must not have been pregnant or must not be pregnant at the time of the study. The email will contain a questionnaire.
We estimate that 120 patients will meet the inclusion and non-inclusion criteria among the patients on the Unit.
Considering that 80 patients (2/3) will answer the questionnaires, we will be able to include 80 patients and 80 controls in our study.
The proportion of women wishing to have children, in the general population, in the study age group is estimated at 90%. Including 160 participants will allow us to show a 20% difference in the proportion of desire to have children in patients with POF, with a power of 90%, an alpha risk of 5% and a bilateral formulation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Questionary patientsWomen aged 18-26 years with congenital (Turner syndrome or other determined or undetermined genetic cause) or acquired (post-therapeutic) |
| Controls | – | Other: Questionary controlsWomen aged 18-26 years who do not have a condition that compromises their fertility |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women aged 18 to 26 with congenital POF (linked to Turner Syndrome or to another determined or undetermined genetic cause) or acquired (post-treatment), having consulted at least once at the bicetre hospital.
Key inclusion criteria (5 listed)
- Women aged 18 to 26
- Diagnosed with POF according to the following criteria:
- Absence of pubertal development or primary or secondary amenorrhea for more than 4 months Follicle Stimulating Hormone (FSH) rate> 40 mL U /L, on at least two separate samples taken at least one month apart Low estradiol level <40 pg / mL
- POF of congenital (Turner syndrome or other genetic cause) or acquired (post-therapeutic) origin
- Who consulted in the Adolescent and Young Adult Gynecology Unit at bicetre Hospital between 2014 and 2021
Key exclusion criteria (7 listed)
- Minor patient or over 26 years old
- Inability to complete the questionnaire
- Lack of social security coverage
- Patient under state medical aid
- Patient under guardianship or curators or under legal protection
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 |
|---|---|---|
| Questionary patientsThe patients will answer 1 questionnaire consisting of 5 parts : * General (demographic information) * Desire for a child * Hospital Anxiety and Depression scale * Sexual life * Additional questions regarding medical care | Other | Patients |
| Questionary controlsWitnesses will complete 1 survey containing 4 parts: * General (demographic information) * Desire to have a child * Hospital Anxiety and Depression scale * Sexual life | Other | Controls |
Primary outcome
Percentage of POI patients expressing a desire for a child (yes/no) compared to controls of the same age with no fertility compromising condition,
Time frame: 3 months
To compare the desire for children of patients with premature ovarian failure (POI) aged 18-26 years with controls of the same age group (inclusion stratified by age in 2-year strata) with no fertility compromising condition.
2 secondary outcomes
Assess the sexual life of women with POF
Time frame: 3 months
Assess the psychological state of women with POF-related infertility and help identify those with symptoms of anxiety or depression.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- 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.
Iris GUILLAUME, Resident contact
Lise DURANTEAU, Doctor principal investigator
Hospital Bicetre
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 Premature Ovarian Failure (POF), 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 7 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: status not confirmed, as of the sponsor's last update on 11 May 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise DURANTEAU, Doctor (00331 45 21 78 41, lise.duranteau@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of POI patients expressing a desire for a child (yes/no) compared to controls of the same age with no fertility compromising condition, (time frame: 3 months). 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 11 May 2021.