Gynecological Impact of Allogeneic Hematopoietic Stem Cell Transplantation in Adults

NCT07048730 | Recruiting

• 1 other identifier: CHUBX 2025/022
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Leukemia

Keywords

Acute leukemia; Allogeneic hematopoietic stem cell transplantation; Premature ovarian failure; Vulvovaginal graft-versus-host disease; Assisted reproductive technologies

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Information on gynecological complications

  2 years

• Pre-transplant fertility consultations

  2 years

• Gynecological follow-up

  2 years

• Cervical cancer screening

  2 years

• HPV vaccination

  2 years

Study Arms (1)

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)

Other: Questionnaire

Interventions

Questionnaire 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)

Questionnaire

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Premature ovarian failure prior to management of haemopathy, post-transplant relapse,
• Patient under legal protection

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU Bordeaux

Bordeaux, France

RECRUITING

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Valerie Bernard, MD, PhD

CONTACT

+33557820940; valerie.bernard@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 2, 2025
• Study Start: September 19, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

FR (1)