Gynecological and Fertility Impact of Allogeneic Hematopoietic Stem Cell Transplantation for Acute Leukemia Diagnosed in Adulthood (GYNEGRAFT)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- Gynecological complication after transplantation
Study Overview
Brief Summary
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
Detailed 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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Questionnaire
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)
Intervention: Questionnaire (Other)
Outcomes
Primary Outcomes
Gynecological complication after transplantation
Time Frame: 2 years
Percentage of women who experienced at least one gynecological complication (premature ovarian failure, vulvovaginal graft-versus-host-disease or cervical pathology related to human papillomavirus infection) 2 years after transplantation.
Gynecological complication after transplantation
Time Frame: 2 years
Percentage of women who experienced at least one gynecological complication (premature ovarian failure, vulvovaginal graft-versus-host-disease or cervical pathology related to human papillomavirus infection) 2 years after transplantation.
Secondary Outcomes
- Gynecological follow-up(2 years)
- Hormone replacement therapy(2 years)
- Bone mineral density(2 years)
- Spontaneous or assisted pregnancy(2 years)
- Psychological disorders(2 years)
- Risk factors associated with the occurrence of gynecological complications(2 years)
- Information on gynecological complications(2 years)
- Pre-transplant fertility consultations(2 years)
- Pre-transplant fertility consultations(2 years)
- Information on gynecological complications(2 years)
- Gynecological follow-up(2 years)
- Cervical cancer screening(2 years)
- HPV vaccination(2 years)
- Hormone replacement therapy(2 years)
- Bone mineral density(2 years)
- Spontaneous or assisted pregnancy(2 years)
- Psychological disorders(2 years)
- Risk factors associated with the occurrence of gynecological complications(2 years)