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NCT Number: NCT07048730

Gynecological Impact of Allogeneic Hematopoietic Stem Cell Transplantation in Adults

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

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Key information

Conditions

Acute Leukemia Adnexal Diseases Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Ovarian Diseases Primary Ovarian Insufficiency Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU Bordeaux

Bordeaux, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. 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.

Secondary outcomes

  1. Information on gynecological complications

    Time frame: 2 years

    Percentage of women who received information on gynecological complications and infertility before allogeneic hematopoietic stem cell transplantation

  2. Pre-transplant fertility consultations

    Time frame: 2 years

    Percentage of pre-transplant fertility consultations

  3. Gynecological follow-up

    Time frame: 2 years

    Percentage of women having gynecological follow-up every six month or every year 2 years after allogeneic hematopoietic stem cell transplantation

  4. Cervical cancer screening

    Time frame: 2 years

    Percentage of women with regular cervical cancer screening 2 years after allogeneic hematopoietic stem cell transplantation

  5. HPV vaccination

    Time frame: 2 years

    Percentage of women vaccinated against HPV post-transplant

  6. Hormone replacement therapy

    Time frame: 2 years

    Percentage of women with hormone replacement therapy 2 years after allogeneic hematopoietic stem cell transplantation

  7. Bone mineral density

    Time frame: 2 years

    Percentage of women who have had a bone mineral density evaluation 2 years after allogeneic hematopoietic stem cell transplantation

  8. Spontaneous or assisted pregnancy

    Time frame: 2 years

    Prevalence of spontaneous or assisted pregnancy after allogeneic hematopoietic stem cell transplantation

  9. Psychological disorders

    Time frame: 2 years

    Prevalence of psychological disorders related to infertility or gynecological complications after allogeneic hematopoietic stem cell transplantation.

  10. Risk factors associated with the occurrence of gynecological complications

    Time frame: 2 years

    Identification of risk factors associated with the occurrence of gynecological complications (conditioning, graft-versus-host disease, age, comorbidities, etc.)

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

Gynecological and Fertility Impact of Allogeneic Hematopoietic Stem Cell Transplantation for Acute Leukemia Diagnosed in Adulthood (GYNEGRAFT)

Acronym: GYNEGRAFT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 2, 2025
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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