Acute LeukemiaGYNEGRAFTNCT07048730
Gynecological Impact of Allogeneic Hematopoietic Stem Cell Transplantation in Adults
A study testing Questionnaire in people with Acute Leukemia, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Acute Leukemia
- What is being tested?
- Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 19 Sep 2025to 5 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Premature ovarian failure prior to management of haemopathy, post-transplant relapse,
- Patient under legal protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gynecological and Fertility Impact of Allogeneic Hematopoietic Stem Cell Transplantation for Acute Leukemia Diagnosed in Adulthood (GYNEGRAFT)
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
Read the 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
- Conditions
- Acute Leukemia
- Being tested
- Questionnaire
- Keywords
- Acute leukemia, Allogeneic hematopoietic stem cell transplantation, Premature ovarian failure, Vulvovaginal graft-versus-host disease, Assisted reproductive technologies
- Medical subject headings
- Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Questionnaire | Experimental | 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) Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (10)
Information on gynecological complications
Percentage of women who received information on gynecological complications and infertility before allogeneic hematopoietic stem cell transplantation
Measured: 2 years
Pre-transplant fertility consultations
Percentage of pre-transplant fertility consultations
Measured: 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
Measured: 2 years
Cervical cancer screening
Percentage of women with regular cervical cancer screening 2 years after allogeneic hematopoietic stem cell transplantation
Measured: 2 years
HPV vaccination
Percentage of women vaccinated against HPV post-transplant
Measured: 2 years
Hormone replacement therapy
Percentage of women with hormone replacement therapy 2 years after allogeneic hematopoietic stem cell transplantation
Measured: 2 years
Bone mineral density
Percentage of women who have had a bone mineral density evaluation 2 years after allogeneic hematopoietic stem cell transplantation
Measured: 2 years
Spontaneous or assisted pregnancy
Prevalence of spontaneous or assisted pregnancy after allogeneic hematopoietic stem cell transplantation
Measured: 2 years
Psychological disorders
Prevalence of psychological disorders related to infertility or gynecological complications after allogeneic hematopoietic stem cell transplantation.
Measured: 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.)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start19 Sep 2025
- Primary completion5 Apr 2026
- Study completion5 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute LeukemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048730
- Sponsor's protocol ID
- CHUBX 2025/022
- Other IDs
- 2025-A00916-43
- Acronym
- GYNEGRAFT
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2025
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gynecological and Fertility Impact of Allogeneic Hematopoietic Stem Cell Transplantation for Acute Leukemia Diagnosed in Adulthood (GYNEGRAFT)
- ClinicalTrials.gov ID
- NCT07048730
- Acronym / sponsor ID
- GYNEGRAFT / CHUBX 2025/022
- Conditions
- Acute Leukemia
- Keywords
- Acute leukemia, Allogeneic hematopoietic stem cell transplantation, Premature ovarian failure, Vulvovaginal graft-versus-host disease, Assisted reproductive technologies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 19 Sep 2025 (actual)
- Primary completion
- 5 Apr 2026 (actual)
- Study completion
- 5 Apr 2026 (actual)
- First posted
- 2 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaire | Experimental | Other: QuestionnaireA 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) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Premature ovarian failure prior to management of haemopathy, post-transplant relapse,
- Patient under legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireA 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) | Other | Questionnaire |
Primary outcome
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.
10 secondary outcomes
Information on gynecological complications
Time frame: 2 years
Pre-transplant fertility consultations
Time frame: 2 years
Gynecological follow-up
Time frame: 2 years
Cervical cancer screening
Time frame: 2 years
HPV vaccination
Time frame: 2 years
Hormone replacement therapy
Time frame: 2 years
Bone mineral density
Time frame: 2 years
Spontaneous or assisted pregnancy
Time frame: 2 years
Psychological disorders
Time frame: 2 years
Risk factors associated with the occurrence of gynecological complications
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire in people with Acute Leukemia, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gynecological complication after transplantation (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.