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NCT Number: NCT03455062

Fertility Study of Women Who Received Organ Transplantation

In terms of immunity, pregnancy can be considered a semi-allogeneic transplant. There are several immunological mechanisms for implantation and maintenance of pregnancy by induction of tolerance without induction of immunosuppression.

This study wants to evaluate the impact of immunodepression on women's fertility by studying the fertility of transplanted cardiac, renal, hepatic and pulmonary women.

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Key information

Conditions

Transplant Fertility

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University Hospital Toulouse

Toulouse, 31059, France

About this study

A study of HIV-positive immunocompromised patients in medically assisted procreation, published in January 2016, found lower rates of implantation, clinical pregnancy, and newborn babies in these patients compared to HIV-negative patients.

Studying the fertility of transplanted immunocompromised women would provide adequate information on fertility and pregnancy possibilities for these patients, study their fertility on a larger scale and finally better understand the role of immunodepression in fertility.

Pregnancy is considered an allogeneic semi-graft, one can question the fertility of these patients under long-term immunosuppressive treatment. In particular, is there an impact on embryo implantation and on the development of pregnancy? To try to answer this problematic, we propose a retrospective non-interventional study to evaluate the birth rate after spontaneous or induced pregnancy in women who have tried to procreate after transplantation.The data will be collected using questionnaires submitted to the women present in the list of patients transplanted from the Organ Transplant Unit (OTU) of Toulouse University Hospital who have agreed to participate. This will make it possible to retrospectively study fertility data in these patients and to carry out, with the necessary hindsight, statistics on pregnancy rates.

The primary outcome measure: birth rate after spontaneous or induced pregnancy in liver, heart, lung or kidney transplant patients who have attempted to procreate post-transplant is a good primary endpoint because it is a unique clinical criterion. relevant to the purpose of the study, specific and objective.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Major patient
  • Patient who has had a heart, kidney, liver, pancreatic or pulmonary transplant for at least 5 years
  • Patients under 40 at the time of transplant
  • Patient having given her no opposition to her participation in research

Exclusion criteria

  • Minor patients
  • Patients over 40 at the time of the transplant
  • Menopausal patients during organ transplantation

Treatment and study plan

Questionnaire about fertility

Other

Recruitment of participants through the list of cardiac, renal, hepatic, pancreatic or pulmonary transplant patients collected from the the Organ Transplant Unit.

A letter from the the Organ Transplant Unit will initially be sent to patients informing them of the study and if they do not wish to participate they can report their opposition by email.

A fertility questionnaire will be send and that will have to be returned by the patient in order to be included in the study.

The questionnaires, anonymous, will be numbered according to their order of return.

Primary outcomes

  1. Birth rate

    Time frame: 1 day

    Birth rate after spontaneous or induced pregnancy in women with heart, kidney, liver, pancreatic or pulmonary transplantation

Secondary outcomes

  1. Rates of ectopic pregnancy

    Time frame: 1 day

    Rates of ectopic pregnancy, early or late spontaneous miscarriage, early or late pregnancy, infants born dead, prematurity in women who have tried to procreate post-transplant.

  2. Rates of desire of pregnancy

    Time frame: 1 day

    Rates of desire of pregnancy in these patients and study of the reasons for this lack of desire for pregnancy

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: FERTIGREFF

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 6, 2018
Registry last updated
Mar 6, 2018

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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