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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A00916-43 | Other Identifier | ANSM |
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Questionnaire | Experimental | A standardized questionnaire was specifically developed for the study to explore:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire | Other | A standardized questionnaire was specifically developed for the study to explore:
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| Measure | Description | Time Frame |
|---|---|---|
| Gynecological complication after transplantation | 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. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Information on gynecological complications | Percentage of women who received information on gynecological complications and infertility before allogeneic hematopoietic stem cell transplantation | 2 years |
| Pre-transplant fertility consultations |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Bordeaux | Bordeaux | France |
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| ID | Term |
|---|---|
| D016649 | Primary Ovarian Insufficiency |
| ID | Term |
|---|---|
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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Percentage of pre-transplant fertility consultations
| 2 years |
| Gynecological follow-up | Percentage of women having gynecological follow-up every six month or every year 2 years after allogeneic hematopoietic stem cell transplantation | 2 years |
| Cervical cancer screening | Percentage of women with regular cervical cancer screening 2 years after allogeneic hematopoietic stem cell transplantation | 2 years |
| HPV vaccination | Percentage of women vaccinated against HPV post-transplant | 2 years |
| Hormone replacement therapy | Percentage of women with hormone replacement therapy 2 years after allogeneic hematopoietic stem cell transplantation | 2 years |
| Bone mineral density | Percentage of women who have had a bone mineral density evaluation 2 years after allogeneic hematopoietic stem cell transplantation | 2 years |
| Spontaneous or assisted pregnancy | Prevalence of spontaneous or assisted pregnancy after allogeneic hematopoietic stem cell transplantation | 2 years |
| Psychological disorders | Prevalence of psychological disorders related to infertility or gynecological complications after allogeneic hematopoietic stem cell transplantation. | 2 years |
| Risk factors associated with the occurrence of gynecological complications | Identification of risk factors associated with the occurrence of gynecological complications (conditioning, graft-versus-host disease, age, comorbidities, etc.) | 2 years |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |