Ignite Creation Date:
2024-05-06 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 12:49 PM
Study NCT ID:
NCT03583294
Status:
UNKNOWN
Last Update Posted:
2018-07-12
First Post:
2018-03-22
Brief Title:
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
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Assistance Publique Hopitaux De Marseille
Study Overview
Official Title:
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
Status Verified Date:
2018-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FERTILEA
Brief Summary:
The French LEA 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 LEA 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 investigators 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 pubertyInclusion 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-32 | OTHER | AP-HM | None |