Skip to content

A Study on the Uterus, Ovarian and Reproductive Functions According to Conditioning Regimen and Pubertal Status at the Time of Stem Cell Transplantation in a Leukemia Pediatric Population

A Study on the Uterus, Ovarian and Reproductive Functions According to Conditioning Regimen and Pubertal Status at the Time of Stem Cell Transplantation in a Leukemia Pediatric Population

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03583294
Acronym
FERTILEA
Enrollment
212
Registered
2018-07-11
Start date
2018-07-01
Completion date
2021-04-01
Last updated
2018-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia

Brief summary

The French L.E.A. (Leucémie Enfant et Adolescent) program was implemented to prospectively evaluate the long-term health status, quality of life and socio-economic status of childhood acute leukemia (CAL) survivors enrolled in French treatment programs from 1980 to present, in 15 cancer centers. Eligible patients for the study are adult women (≥18 years) from L.E.A. cohort. Project has been approved by the Scientific Advisory Board and the Steering Committee of LEA Cohort. MRI uterus anatomy, follicular ovarian reserve and reproductive function will be assess in 212 adult women who received a hematopoietic stem cell transplantation (HSCT) for CAL. The investigator's objective is to correlate uterus and ovarian function to the conditioning regimen received before HSCT (total body irradiation (TBI) or busulfan - based conditioning) and the pubertal status at the HSCT (before or after puberty).Inclusion period is planned for 2 years. Four patient groups will be compared: * Group 1: HSCT before nine years and after conditioning regimen with TBI (12 Gy) * Group 2: HSCT before nine years and after a busulfan-based conditioning regimen * Group 3: HSCT after nine years and after conditioning regimen with TBI (12 Gy) * Group 4: HSCT after nine years and after a busulfan-based conditioning regimen Information will be collected during specific medical visit in one of the investigatory centers. Pelvic MRI and hormonal blood tests will be performed and a medical consultation with a physician specialized in reproductive medicine and oncofertility will be proposed to eligible patients. Data assessed for each women are the following: * Disease type, age and pubertal status at HSCT, age at evaluation, therapy lines before and after HSCT, conditioning regimen, relapse after HSCT if applicable. Cumulative doses of cyclophosphamide, melphalan, busulfan and radiation will be collected from the LEA database. * Gynecological characteristics: spontaneous or induced puberty, spontaneous menstrual cycles or Hormone Substitutive treatment (HRT) or amenorrhea without HRT; gestity parity (if pregnancy: spontaneous, after Assisted Reproductive Technologies?), history of ovarian cryopreservation, was information given (and at what age?) about risk of premature ovarian failure and about the gyneco-obstetrical impact of conditioning regimen for HSCT? * Ovarian follicular reserve: FSH, LH, estradiol, Anti-Müllerian Hormon (AMH) at the day 2-3 of the cycle or whenever if amenorrhea. Ovarian volume and antral Follicle Count will be performed with pelvic sonography. * Uterine anatomy by MRI, at the end of follicular phase or after estrogen therapy, in order to measure proliferative endometrium. Anatomical parameters will be compare to normal measurements of uterus: uterine volume, myometrial, endometrial and junctionnal zone thickness, cervical length, apparent diffusion coefficient values. * Reproductive function: spontaneous pregnancy rate or after ART (IVF, oocyte donation), term and mode of delivery, health of the child.

Interventions

OTHERMRI pelvic

Pelvic MRI

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Female treated for acute/chronic myeloide leukemia during chidwood and survived from this desease

Exclusion criteria

* Female with uneligible MRI exam conditions

Design outcomes

Primary

MeasureTime frameDescription
Uterin Anatomy1 dayPelvic echography: Quantitative estimation of the residual ovarian reserve with the count of antral follicles and the thickness of the endometrium and ovarian volume Pelvic IRM: the maximum size of functional endometrium in the proliferative phase

Countries

France

Contacts

Primary ContactBlandine COURBIERE, MD/PhD
blandine.courbiere@ap-hm.fr+33 491383675

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026