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Access to Parenthood and Gynecological Follow-up After Organ Transplantation

Access to Parenthood and Gynecological Follow-up After Organ Transplantation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05610670
Acronym
FerGyTransplan
Enrollment
116
Registered
2022-11-09
Start date
2022-10-10
Completion date
2023-11-23
Last updated
2025-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parenthood Status, Transplant Kidney, Transplant Lung

Brief 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. 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.

Interventions

OTHERQuestionnaire

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.

Sponsors

Hopital Foch
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Transplantectomy within 1 year (kidney) or 2 years (lung) of transplantation * Be deprived of liberty or under guardianship * Not speaking or understanding French

Design outcomes

Primary

MeasureTime frameDescription
Pregnancy rate1 month after inclusionPregnancy 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

Secondary

MeasureTime frameDescription
Gynecological evaluation post-transplant1 month after inclusionFrequency of gynecological follow-up, date of return of cycles, evaluation of contraception and occurrence of post-transplant cervical dysplasia
Satisfaction with information received regarding the risks of post-transplant pregnancy1 month after inclusionSatisfaction 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)
Patients' experience1 month after inclusionpatients' 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).
Conception time1 month after inclusionConception time
use of MPA1 month after inclusionnumber of participants who used of MPA

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026