Gynecological Impact of Allogeneic Hematopoietic Stem Cell Transplantation in Adults (GYNEGRAFT)

University Hospital of Bordeaux

Status: Enrolling

Conditions: Acute Leukemia

Treatments: Other: Questionnaire

Study type: Interventional

Funder types: Other

Identifiers

NCT07048730

CHUBX 2025/022

Details and patient eligibility

About

Gynecological impact and infertility are major issues for women after allogeneic hematopoietic stem cell transplantation.

The aim of the present study is to investigate the prevalence of gynecological complications after allogeneic hematopoietic stem cell transplantation for acute leukemia in adulthood. By conducting a single-center retrospective descriptive analysis, the prevalence, follow-up and treatment of gynecological complications -including premature ovarian failure, vulvovaginal graft-versus-host-disease, cervical pathology- will be analysed

Full description

Recent advances in the treatment of acute leukemia, notably through allogeneic hematopoietic stem cell transplantation, have markedly improved survival rates. However, these therapies are associated with significant gonadotoxic and immunosuppressive effects that adversely impact gynecological and reproductive health- including premature ovarian failure (POF), vulvovaginal graft-versus-host-disease and cervical pathology related to human papillomavirus (HPV) infection. POF is a very frequent complication that induce hypoestrogenic symptoms and long-term side effects such as osteoporosis and cardiovascular disease. POF also induce infertility; spontaneous pregnancies after allogeneic hematopoietic stem cell transplantation are very rare. In most cases, pregnancies are obtained thanks to oocyte donation. In oncology, recent advances in fertility preservation offer promising prospects, including in emergency situations. Among these approaches, ovarian cortex cryopreservation can be proposed. However, this method remains limited in hematology due to the risk of reintroducing residual leukemic cells when cryopreserved tissue is reused, a challenge that is currently an area of research. In this context, a specialist fertility consultation prior to allograft is recommended.

Most studies concerning gynecological impact of acute leukemia focus on patients transplanted during childhood and data concerning women diagnosed in adulthood is limited. Comprehensive evaluation of gynecological and fertility impact in women treated in adulthood is thus essential

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women diagnosed with acute leukemia, who underwent allogeneic hematopoietic stem cell transplantation in adulthood (>18 years),
• Aged 20 to 45 at the time of evaluation,
• At least 2 years post-transplant.
• French-speaking patients, without comprehension disorders, and literate,
• No objection to participation.

Exclusion criteria

• Premature ovarian failure prior to management of haemopathy, post-transplant relapse,
• Patient under legal protection

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Questionnaire

Experimental group

Description:

A standardized questionnaire was specifically developed for the study to explore: * Women's socio-demographic data * Data about their hematological disease (type of leukemia, conditioning protocol, relapses, graft-versus-host disease etc.) * Information received by patients prior to transplantation concerning gynecological complications * Symptoms, screening, diagnosis and treatment of the main gynecological complications * Patients fertility (spontaneous or after assisted reproductive treatments)

Treatment:

Other: Questionnaire