Gynecological and fertility effects after allogeneic stem cell transplant in adults
Gynecological and Fertility Impact of Allogeneic Hematopoietic Stem Cell Transplantation for Acute Leukemia Diagnosed in Adulthood (GYNEGRAFT)
This project sees how often gynecological problems and infertility happen in adult women who had an allogeneic hematopoietic stem cell transplant for acute leukemia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 1 site (Bordeaux) |
| Trial ID | NCT07048730 on ClinicalTrials.gov |
What this trial studies
This is a single-center, retrospective descriptive analysis at CHU Bordeaux using patient questionnaires and medical records to document gynecological complications after allogeneic hematopoietic stem cell transplantation in adults. The study will record the prevalence, timing, follow-up, and treatments for conditions such as premature ovarian failure, vulvovaginal graft-versus-host disease, and cervical pathology related to HPV. Eligible participants are French-speaking women aged 20–45 at evaluation who were transplanted as adults and are at least two years post-transplant. Results aim to better define the burden of gynecological morbidity and inform counseling and fertility-preservation practices.
Who should consider this trial
Good fit: Adult women (transplanted at age 18 or older) with a history of acute leukemia who are at least two years post-allogeneic hematopoietic stem cell transplant, aged 20–45 at evaluation, French-speaking, and able to complete a questionnaire.
Not a fit: Men, children, women transplanted as minors, non–French-speaking patients, those with prior premature ovarian failure before their hematologic treatment, patients with post-transplant relapse, or those under legal protection are not suitable and likely will not benefit from this analysis.
Why it matters
Potential benefit: If successful, findings could improve counseling, screening, and fertility-preservation planning for women before and after allogeneic transplant.
How similar studies have performed: Related retrospective studies exist mainly in cohorts transplanted during childhood, but adult-focused prevalence data are limited, so this analysis addresses a less-studied population.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bordeaux
- CHU Bordeaux — Bordeaux, France (Recruiting)
Study contacts
- Study coordinator: Valerie Bernard, MD, PhD
- Email: valerie.bernard@chu-bordeaux.fr
- Phone: +33557820940
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.