Fertility, Transplant
Conditions
Keywords
Transplant, fertility
Brief summary
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.
Detailed description
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.
Interventions
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.
Sponsors
University Hospital, Toulouse
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Birth rate | 1 day | Birth rate after spontaneous or induced pregnancy in women with heart, kidney, liver, pancreatic or pulmonary transplantation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rates of ectopic pregnancy | 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. |
| Rates of desire of pregnancy | 1 day | Rates of desire of pregnancy in these patients and study of the reasons for this lack of desire for pregnancy |
Countries
France
Outcome results
None listed