Parenthood StatusFerGyTransplanNCT05610670
Access to Parenthood and Gynecological Follow-up After Organ Transplantation
A study testing Questionnaire in people with Parenthood Status and Transplant Lung, run by Hopital Foch at 1 site in France.
Trial summary
Solid organ transplants affect subjects of all ages, including young women of childbearing age. The improvement in the management of young female transplant patients makes it possible to consider pregnancies, about which the literature reports reassuring data on small series. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Parenthood Status, Transplant Lung, Transplant Kidney
- What is being tested?
- Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteFrance
- Study dates
- 10 Oct 2022to 23 Nov 2023
- Phase
- Interventional
- 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
Who may be able to join
- Women treated at the Foch Hospital for kidney/pulmonary transplantation or for kidney transplantation at the Bicêtre Hospital from 2010 to 2018 (lung) and 2019 (kidney)
- Having been transplanted before the age of 40
- Over 18 years of age
- Have signed a consent form
- Affiliated to a health insurance plan
Who cannot join
- Transplantectomy within 1 year (kidney) or 2 years (lung) of transplantation
- Be deprived of liberty or under guardianship
- Not speaking or understanding French
Trial locations and contacts
1 site in 1 country.
About this study
Solid organ transplants affect subjects of all ages, including young women of childbearing age. The improvement in the management of young female transplant patients makes it possible to consider pregnancies, about which the literature reports reassuring data on small series. The question of gynecological follow-up, access to parenthood, as well as the information and experience of patients regarding these issues after transplantation have thus become topical issues.
Read the detailed description
Nowadays, solid organ transplantation is a common procedure performed all over the world on patients of all ages. It represents about 900,000 procedures per year worldwide and a little over 6,100 in France (who.int). It has become indispensable for treating certain pathologies: for example, renal transplantation is the best alternative for treating end-stage renal failure, both from the point of view of effectiveness and medical benefit for the patient and from an economic standpoint. As the indications are increasingly broad, the Foch Hospital is the leading French center for lung transplantation mainly on patients with cystic fibrosis but recently transplanted a lung on a patient with end-stage respiratory failure due to Covid-19.
Patients who have undergone a solid organ transplantation require, after the procedure and more generally throughout their life, a global management by a multidisciplinary team in order to maintain a regular and adapted surveillance, in particular because of the immunosuppressive treatments, which are subject to numerous complications (benefit-risk balance between the rejection episodes and the infectious and carcinological risks).
Pregnancy adds an increased risk of morbidity for transplant patients of childbearing age. However, progress in terms of follow-up and post-transplant treatment increasingly allows them to be authorized. In the literature, there are already some reassuring series on the course of pregnancies after renal or pulmonary transplantation, but the studies are very often limited to strict obstetrical and neonatal criteria.
Moreover, the risk of cervical dysplasia is increased in transplant patients. While the HAS recommends "joint and close follow-up between the referring physician and the gynecologist", the gynecological follow-up of young women after solid organ transplantation does not meet any specific recommendation at present.
Finally, the question of parenthood has a major place in our societies. It is in this context that it seems interesting to us to look at the gynecological follow-up of transplant patients by integrating pregnancies and their outcomes, but also the patients' experiences with regard to their desire for parenthood.
- Conditions
- Parenthood Status, Transplant Lung, Transplant Kidney
- Being tested
- Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
The questionnaire will allow us to complete the information and to collect their experiences regarding the desire and/or achievement of a pregnancy, but also their gynecological follow-up in the broad sense, on the other hand.
| Study group | Role | What they receive |
|---|---|---|
| Patients who underwent a kidney/pulmonary transplant before the age of 40 | Other | The questionnaire will allow us to complete the information not obtained from the patients' files on the one hand, and to collect their experiences regarding the desire and/or achievement of a pregnancy, but also their gynecological follow-up in the broad sense, on the other hand. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate
Pregnancy rate (defined as the number of confirmed pregnancies (positive urine or plasma pregnancy test) out of the number of patients with a pregnancy desire) and obstetrical outcomes in renal/pulmonary transplant patients with a pregnancy desire
Measured: 1 month after inclusion
Secondary outcomes (5)
Gynecological evaluation post-transplant
Frequency of gynecological follow-up, date of return of cycles, evaluation of contraception and occurrence of post-transplant cervical dysplasia
Measured: 1 month after inclusion
Satisfaction with information received regarding the risks of post-transplant pregnancy
Satisfaction with information received regarding the risks of post-transplant pregnancy prior to transplantation on a scale of 1 to 5 (1 : not good at all - 5 : very good)
Measured: 1 month after inclusion
Patients' experience
patients' experience of their parental project and the support of the medical team in the event of difficulties in accessing parenthood (scale from 1 to 5, 1 : not good at all - 5 : very good).
Measured: 1 month after inclusion
Conception time
Conception time
Measured: 1 month after inclusion
use of MPA
number of participants who used of MPA
Measured: 1 month after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start10 Oct 2022
- Primary completion23 Nov 2023
- Study completion23 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parenthood StatusStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05610670
- Sponsor's protocol ID
- 2020_0181
- Acronym
- FerGyTransplan
- Status last verified
- Mar 2025
- First submitted
- 10 Oct 2022
- Last updated
- 7 Mar 2025
- 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 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Access to Parenthood and Gynecological Follow-up After Organ Transplantation
- ClinicalTrials.gov ID
- NCT05610670
- Acronym / sponsor ID
- FerGyTransplan / 2020_0181
- Conditions
- Parenthood Status, Transplant Lung, Transplant Kidney
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 23 Nov 2023 (actual)
- Study completion
- 23 Nov 2023 (actual)
- First posted
- 9 Nov 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.
Solid organ transplants affect subjects of all ages, including young women of childbearing age. The improvement in the management of young female transplant patients makes it possible to consider pregnancies, about which the literature reports reassuring data on small series. The question of gynecological follow-up, access to parenthood, as well as the information and experience of patients regarding these issues after transplantation have thus become topical issues.
Detailed description
Nowadays, solid organ transplantation is a common procedure performed all over the world on patients of all ages. It represents about 900,000 procedures per year worldwide and a little over 6,100 in France (who.int). It has become indispensable for treating certain pathologies: for example, renal transplantation is the best alternative for treating end-stage renal failure, both from the point of view of effectiveness and medical benefit for the patient and from an economic standpoint. As the indications are increasingly broad, the Foch Hospital is the leading French center for lung transplantation mainly on patients with cystic fibrosis but recently transplanted a lung on a patient with end-stage respiratory failure due to Covid-19.
Patients who have undergone a solid organ transplantation require, after the procedure and more generally throughout their life, a global management by a multidisciplinary team in order to maintain a regular and adapted surveillance, in particular because of the immunosuppressive treatments, which are subject to numerous complications (benefit-risk balance between the rejection episodes and the infectious and carcinological risks).
Pregnancy adds an increased risk of morbidity for transplant patients of childbearing age. However, progress in terms of follow-up and post-transplant treatment increasingly allows them to be authorized. In the literature, there are already some reassuring series on the course of pregnancies after renal or pulmonary transplantation, but the studies are very often limited to strict obstetrical and neonatal criteria.
Moreover, the risk of cervical dysplasia is increased in transplant patients. While the HAS recommends "joint and close follow-up between the referring physician and the gynecologist", the gynecological follow-up of young women after solid organ transplantation does not meet any specific recommendation at present.
Finally, the question of parenthood has a major place in our societies. It is in this context that it seems interesting to us to look at the gynecological follow-up of transplant patients by integrating pregnancies and their outcomes, but also the patients' experiences with regard to their desire for parenthood.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who underwent a kidney/pulmonary transplant before the age of 40 | Other | Other: QuestionnaireThe questionnaire will allow us to complete the information not obtained from the patients' files on the one hand, and to collect their experiences regarding the desire and/or achievement of a pregnancy, but also their gynecological follow-up in the broad sense, on the other hand. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women treated at the Foch Hospital for kidney/pulmonary transplantation or for kidney transplantation at the Bicêtre Hospital from 2010 to 2018 (lung) and 2019 (kidney)
- Having been transplanted before the age of 40
- Over 18 years of age
- Have signed a consent form
- Affiliated to a health insurance plan
Key exclusion criteria (3 listed)
- Transplantectomy within 1 year (kidney) or 2 years (lung) of transplantation
- Be deprived of liberty or under guardianship
- Not speaking or understanding French
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 |
|---|---|---|
| QuestionnaireThe questionnaire will allow us to complete the information and to collect their experiences regarding the desire and/or achievement of a pregnancy, but also their gynecological follow-up in the broad sense, on the other hand. | Other | Patients who underwent a kidney/pulmonary transplant before the age of 40 |
Primary outcome
Pregnancy rate
Time frame: 1 month after inclusion
Pregnancy rate (defined as the number of confirmed pregnancies (positive urine or plasma pregnancy test) out of the number of patients with a pregnancy desire) and obstetrical outcomes in renal/pulmonary transplant patients with a pregnancy desire
5 secondary outcomes
Gynecological evaluation post-transplant
Time frame: 1 month after inclusion
Satisfaction with information received regarding the risks of post-transplant pregnancy
Time frame: 1 month after inclusion
Patients' experience
Time frame: 1 month after inclusion
Conception time
Time frame: 1 month after inclusion
use of MPA
Time frame: 1 month after inclusion
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 7 Mar 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire in people with Parenthood Status and Transplant Lung, run by Hopital Foch 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 7 Mar 2025. 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?
Pregnancy rate (time frame: 1 month after inclusion). 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 7 Mar 2025.