LeukemiaFERTILEANCT03583294
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 testing MRI pelvic in people with Leukemia, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Leukemia
- What is being tested?
- MRI pelvic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2018to 1 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female treated for acute/chronic myeloide leukemia during chidwood and survived from this desease
Who cannot join
- Female with uneligible MRI exam conditions
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hopitaux de Marseille
Marseille, 13354
Blandine Courbiere, MD/PhD, blandine.courdbiere@ap-hm.fr
About this study
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
Read more
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.
- Conditions
- Leukemia
- Being tested
- MRI pelvic
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI pelvicOther
Pelvic MRI
| Study group | Role | What they receive |
|---|---|---|
| irradiation regimen before 9 | Experimental | Female who received a hematopoietic stem cell transplantation (HSCT) for AML/CML before 9 years old after conditioning regimen with total body irradation MRI pelvic will be performed Receives: Other: MRI pelvic |
| busulfan regimen before 9 | Experimental | Female who received a hematopoietic stem cell transplantation (HSCT) for AML/CML before 9 years old after a busulfan-based conditioning regimen MRI pelvic will be performed Receives: Other: MRI pelvic |
| irradiation regimen after 9 | Experimental | Female who received a hematopoietic stem cell transplantation (HSCT) for AML/CML after 9 years old after conditioning regimen with total body irradation MRI pelvic will be performed Receives: Other: MRI pelvic |
| busulfan regimen after 9 | Experimental | Female who received a hematopoietic stem cell transplantation (HSCT) for AML/CML after 9 years old after a busulfan-based conditioning regimen MRI pelvic will be performed Receives: Other: MRI pelvic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uterin Anatomy
Pelvic 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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start1 Jul 2018 (estimated)
- Primary completion1 Apr 2020 (estimated)
- Study completion1 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EMILIE GARRIDO PRADALIE, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03583294
- Sponsor's protocol ID
- 2017-32
- Other IDs
- 2017-32
- Acronym
- FERTILEA
- Status last verified
- Mar 2018
- First submitted
- 22 Mar 2018
- Last updated
- 12 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Courbiere B, Drikes B, Grob A, Hamidou Z, Saultier P, Bertrand Y, Gandemer V, Plantaz D, Plat G, Poiree M, Ducassou S, Pochon C, Dalle JH, Thouvenin S, Paillard C, Kanold J, Sirvent A, Rousset-Jablonski C, Duros S, Gueniffey A, Cohade C, Boukaidi S, Frantz S, Agopiantz M, Poirot C, Genod A, Pirrello O, Gremeau AS, Bringer-Deutsch S, Auquier P, Michel G. The uterine volume is dramatically decreased after hematopoietic stem cell transplantation during childhood regardless of the conditioning regimen. Fertil Steril. 2023 Apr;119(4):663-672. doi: 10.1016/j.fertnstert.2022.12.040. Epub 2023 Jan 7.
PubMed 36627013
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03583294
- Acronym / sponsor ID
- FERTILEA / 2017-32
- Conditions
- Leukemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 1 Jul 2018 (estimated)
- Primary completion
- 1 Apr 2020 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 11 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| irradiation regimen before 9 | Experimental | Other: MRI pelvicFemale who received a hematopoietic stem cell transplantation (HSCT) for AML/CML before 9 years old after conditioning regimen with total body irradation MRI pelvic will be performed |
| busulfan regimen before 9 | Experimental | Other: MRI pelvicFemale who received a hematopoietic stem cell transplantation (HSCT) for AML/CML before 9 years old after a busulfan-based conditioning regimen MRI pelvic will be performed |
| irradiation regimen after 9 | Experimental | Other: MRI pelvicFemale who received a hematopoietic stem cell transplantation (HSCT) for AML/CML after 9 years old after conditioning regimen with total body irradation MRI pelvic will be performed |
| busulfan regimen after 9 | Experimental | Other: MRI pelvicFemale who received a hematopoietic stem cell transplantation (HSCT) for AML/CML after 9 years old after a busulfan-based conditioning regimen MRI pelvic will be performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female treated for acute/chronic myeloide leukemia during chidwood and survived from this desease
Key exclusion criteria (1 listed)
- Female with uneligible MRI exam conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI pelvicPelvic MRI | Other | busulfan regimen after 9, busulfan regimen before 9, irradiation regimen after 9, irradiation regimen before 9 |
Primary outcome
Uterin Anatomy
Time frame: 1 day
Pelvic 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2018.
- Derived from this study: PubMed 36627013Courbiere B, Drikes B, Grob A, Hamidou Z, Saultier P, Bertrand Y, Gandemer V, Plantaz D, Plat G, Poiree M, Ducassou S, Pochon C, Dalle JH, Thouvenin S, Paillard C, Kanold J, Sirvent A, Rousset-Jablonski C, Duros S, Gueniffey A, Cohade C, Boukaidi S, Frantz S, Agopiantz M, Poirot C, Genod A, Pirrello O, Gremeau AS, Bringer-Deutsch S, Auquier P, Michel G. The uterine volume is dramatically decreased after hematopoietic stem cell transplantation during childhood regardless of the conditioning regimen. Fertil Steril. 2023 Apr;119(4):663-672. doi: 10.1016/j.fertnstert.2022.12.040. Epub 2023 Jan 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
EMILIE GARRIDO PRADALIE study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI pelvic in people with Leukemia, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Blandine COURBIERE, MD/PhD (+33 491383675, blandine.courbiere@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uterin Anatomy (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03583294, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2018.