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Gynecological Impact of Allogeneic Hematopoietic Stem Cell Transplantation in Adults

NCT ID: NCT07048730

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-19

Study Completion Date

2026-07-31

Brief Summary

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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

Detailed Description

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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

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Acute Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

Questionnaire

Intervention Type OTHER

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)

Interventions

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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 Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Bordeaux

Bordeaux, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Valerie Bernard, MD, PhD

Role: CONTACT

[email protected]
+33557820940

Facility Contacts

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Valerie Baernard, MD, PhD

Role: primary

[email protected]
+33557820940

Other Identifiers

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CHUBX 2025/022

Identifier Type: -

Identifier Source: org_study_id