Acute Leukemia
Conditions
Keywords
Acute leukemia, Allogeneic hematopoietic stem cell transplantation, Premature ovarian failure, Vulvovaginal graft-versus-host disease, Assisted reproductive technologies
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
Interventions
OTHERQuestionnaire
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)
Sponsors
University Hospital, Bordeaux
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gynecological complication after transplantation | 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
| Measure | Time frame | Description |
|---|---|---|
| Information on gynecological complications | 2 years | Percentage of women who received information on gynecological complications and infertility before allogeneic hematopoietic stem cell transplantation |
| Pre-transplant fertility consultations | 2 years | Percentage of pre-transplant fertility consultations |
| Gynecological follow-up | 2 years | Percentage of women having gynecological follow-up every six month or every year 2 years after allogeneic hematopoietic stem cell transplantation |
| Cervical cancer screening | 2 years | Percentage of women with regular cervical cancer screening 2 years after allogeneic hematopoietic stem cell transplantation |
| HPV vaccination | 2 years | Percentage of women vaccinated against HPV post-transplant |
| Hormone replacement therapy | 2 years | Percentage of women with hormone replacement therapy 2 years after allogeneic hematopoietic stem cell transplantation |
| Bone mineral density | 2 years | Percentage of women who have had a bone mineral density evaluation 2 years after allogeneic hematopoietic stem cell transplantation |
| Spontaneous or assisted pregnancy | 2 years | Prevalence of spontaneous or assisted pregnancy after allogeneic hematopoietic stem cell transplantation |
| Psychological disorders | 2 years | Prevalence of psychological disorders related to infertility or gynecological complications after allogeneic hematopoietic stem cell transplantation. |
| Risk factors associated with the occurrence of gynecological complications | 2 years | Identification of risk factors associated with the occurrence of gynecological complications (conditioning, graft-versus-host disease, age, comorbidities, etc.) |
Countries
France
Outcome results
None listed