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NCT Number: NCT06279676

Improvement of Women's Health After Allogeneic Stem Cell Transplantation

The aim of this prospective research project is to better understand vulvovaginal cGVHD to improve care of allografted women. The expected outcomes include better knowledge of the incidence and manifestations of vulvovaginal cGVHD, risk factors, response to treatments and impact on sexual health of allotransplanted female patients. The knowledge acquired will allow transplant clinicians to make more precise recommendations for gynecological management of future allografted women.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

CIUSSS de l'Est-de-l'Ile-de-Montréal / Hôpital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location status: Recruiting

Location contact

Jean Roy, Dr.

CONTACT

[email protected]

514-252-3404

About this study

The invetigators plan to recruit 100 women who will be evaluated 9 times over a period of 2 years (before allograft, at + 3 months, +6 months, +9 months, +12 months, +15 months, +18 months, +21 months, and +24 months +/- 14 days). If a new diagnosis of cGVHD is made between 2 visits, an additional gynecological examination will be performed.

Visits by the Hôpital Maisonneuve-Rosemont Hospital transplant team will include a physical examination to assess for the presence of cGVHD using the NIH criteria. The FACT-BMT quality of life questionnaire will also be completed before the allograft, at 3 months and 6 months after transplant. If cGVHD is diagnosed, the participants will also have to complete two questionnaires specific to cGVHD (Lee Scale for cGVHD, Patient self-assessment of cGVHD) at diagnosis and then at + 6, +12, +18 and +24 months from day 0 of allograft.

Assessments by CHUM gynecologists will take place before the allograft, then at +3, +6, +12, +18 and +24 months from day 0 of the allograft and will include: a vulvar/vaginal examination, a sample for HPV testing and sexual health questionnaires to be completed (Personal assessment of intimacy within relationships - PAIR, Female Sexual Function Index - FSFI , Female Sexual Distress Scale-Revised - FSDS-R).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All women aged 18 and over who will receive a first allogeneic HSCT (bone marrow, peripheral blood stem cells from a related, unrelated (including cord blood) or haploidentical donor) at the CIUSSS-EMTL. Recruitment will begin when the project receives ethical approval. Recruitment period will be of 2 to 3 years.

Exclusion criteria

  • Those who receive a second HSCT allograft.
  • Those who receive an autologous transplant.
  • Inability to give informed consent.
  • Unable to communicate in French or English.
  • Any other reason which, according to the investigators, makes it preferable for a patient not to participate.

Treatment and study plan

Primary outcomes

  1. Define the incidence and describe clinical presentation of vulvovaginal cGVHD after allogeneic stem cell transplants reflecting modern transplant practice.

    Time frame: From -1 month of transplant until +24 months after.

    Prospective history, physical exam with focus on cGVHD.

Secondary outcomes

  1. Evaluate genital cGVHD treatment response

    Time frame: From diagnosis until 24 months post transplant

    Medical evaluation of vulvovaginal cGVHD according to NIH 2014 criteria

  2. Evaluate the frequency of premature ovarian failure

    Time frame: 3, 6 and 12 months post transplant

    Percentage of patients with premature ovarian failure

  3. Measure the incidence and prevalence of HPV infection

    Time frame: 3, 6 and 12 months post transplant

    Number of patients with HPV infection

  4. Evaluate the quality of life (QoL) of allografted women

    Time frame: At screening and 3, 6, 12, 18 and 24 months post transplant

    Measure of QoL using FACT-BMT standardized questionnaire

  5. Evaluate intimacy within relationships of allografted women

    Time frame: At screening and 6,12,18 and 24 months post transplant

    Measure of sexual health using the Personal Assessment of Intimacy within Relationships (PAIR) standardized questionnaire

  6. Evaluate sexual function of allografted women

    Time frame: At screening and 6,12,18 and 24 months post transplant

    Measure of sexual health using the Female Sexual Function Index (FSFI) standardized questionnaire

  7. Evaluate sexual distress of allografted women

    Time frame: At screening and 6,12,18 and 24 months post transplant

    Measure of sexual health using the Female Sexual Distress Scale-Revised (FSD-R) standardized questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Michel-Olivier Gratton

CONTACT

[email protected]

514-252-3400 ext. 2397

Sponsors and collaborators

Lead sponsor

Ciusss de L'Est de l'Île de Montréal

Other

Collaborators

  • Centre hospitalier de l'Université de Montréal (CHUM)

Registry information

Acronym: SaFeGreff

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Feb 28, 2024
Registry last updated
Mar 18, 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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