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Completed

NCT Number: NCT05610670

Access to Parenthood and Gynecological Follow-up After Organ Transplantation

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Foch

Suresnes, 92150, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Questionnaire

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Gynecological evaluation post-transplant

    Time frame: 1 month after inclusion

    Frequency of gynecological follow-up, date of return of cycles, evaluation of contraception and occurrence of post-transplant cervical dysplasia

  2. Satisfaction with information received regarding the risks of post-transplant pregnancy

    Time frame: 1 month after inclusion

    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)

  3. Patients' experience

    Time frame: 1 month after inclusion

    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).

  4. Conception time

    Time frame: 1 month after inclusion

    Conception time

  5. use of MPA

    Time frame: 1 month after inclusion

    number of participants who used of MPA

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Acronym: FerGyTransplan

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 9, 2022
Registry last updated
Mar 7, 2025

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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