Fertility Study of Women Who Received Organ Transplantation

Fertility Clinical Trial

— FERTIGREFF  

Official title:

Fertility Study of Women Who Received Organ Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03455062
• Other study ID #: RC31/17/0092
• Secondary ID: 2017-A00913-50
• Status: Completed
• Phase: N/A
• First received: February 27, 2018
• Last updated: February 27, 2018
• Start date: September 1, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: February 2018
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fertility
• Transplant

Intervention

Other:
• Questionnaire about fertility
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.

Locations

Country	Name	City	State
France	University Hospital Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Birth rate	Birth rate after spontaneous or induced pregnancy in women with heart, kidney, liver, pancreatic or pulmonary transplantation	1 day
Secondary	Rates of ectopic pregnancy	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.	1 day
Secondary	Rates of desire of pregnancy	Rates of desire of pregnancy in these patients and study of the reasons for this lack of desire for pregnancy	1 day