Gynecological and Fertility Impact of Allogeneic Hematopoietic Stem Cell Transplantation for Acute Leukemia Diagnosed in Adulthood (GYNEGRAFT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Gynecological complication after transplantation
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Premature ovarian failure prior to management of haemopathy, post-transplant relapse,
- •Patient under legal protection
研究组 & 干预措施
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)
干预措施: Questionnaire (Other)
结局指标
主要结局
Gynecological complication after transplantation
时间窗: 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
时间窗: 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.
次要结局
- 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)