Ovarian Tissue TransplantationCAROLéLISANCT02184806
Autograft of Human Ovarian Tissue : Efficiency and Safety
A study testing orthotopic graft and heterotopic graft in people with Ovarian Tissue Transplantation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Ovarian tissue cryopreservation is a new technique for female fertility preservation. One way to restore fertility is autotransplantation of ovarian tissue. The principal purpose of this study will be to evaluate the efficiency and safety of this procedure. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Ovarian Tissue Transplantation
- What is being tested?
- orthotopic graft and heterotopic graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2010to Jan 2019
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- adult women (age ≥ 18 years old) who stored ovarian fragments before gonadotoxic treatments
- Women who desire to conceive
- Married women or in stable couple
- Cured women or in remission
- Women suffering of Premature ovarian failure
- Consenting women
- women with health insurance
Who cannot join
- age < 18 years
- women with normal ovarian function
- women with a disease at high risk for ovarian metastasis
- women with contraindication for surgery
- women with contraindication for pregnancy
- not cured women or not in remission
- women without health insurance
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Tenon, service de Biologie de la reproduction
Paris, 75020
Poirot Catherine, MD, PhD, +33 1 56 01 78 00, Catherine.poirot@tnn.aphp.fr
About this study
Official title: Autograft of Human Ovarian Tissue: Efficiency and Safety Evaluation
Ovarian tissue cryopreservation is a new technique for female fertility preservation. One way to restore fertility is autotransplantation of ovarian tissue.
The principal purpose of this study will be to evaluate the efficiency and safety of this procedure.
Read the detailed description
Ovarian tissue cryopreservation is a new technique for female fertility preservation before gonadotoxic treatments. The first ovarian tissue cryopreservations were performed 10 years ago. There are two main methods to use frozen ovarian cortex: autograft of ovarian fragments and in vitro follicular growth. At the present time, none mature oocytes were obtained after culture. Since 2000, around twenty publications stating autografts of ovarian cortex reported 8 pregnancy and 6 life birth of healthy babies.
Since 1998 until 2008, in the unit of reproduction biology of pitie-salpetriere hospital in Paris, France, 330 patients have had an ovarian tissue cryopreservation for fertility preservation before gonadotoxic treatment. Among them, at the present time, 180 have a procreative age and in consequence, could ask for the use of their ovarian cortex.
The general aim of this protocol will be to propose to women wishing to have a baby, an ovarian tissue transplantation if the patients have an premature ovarian failure.
The principal aim of this study will be to evaluate the efficiency and the safety of ovarian transplantation.
Before grafting, the absence of contra- indication will be check. An informed consent will be signed by the patient. Autograft of ovarian cortex will be performed either in orthotopic or in heterotopic localization according to the pathology and a possible contra-indication to orthotopic position.
After graft, each month hormonal assessment, ovarian echography and, after 3 months, an MRI, will be performed.
Assisted Reproductive Technologies (ART) will be performed in case of heterotopic graft and if necessary in case of orthotopic graft.
The efficiency of ovarian tissue autograft will be appreciated by the delay before the recovery of the ovarian function, the oocyte and embryos qualities in case of ART.
Finally, the number of pregnancies and live births will be also appreciated as well as a possible recurrence of the pathology.
- Conditions
- Ovarian Tissue Transplantation
- Being tested
- orthotopic graft, heterotopic graft
- Keywords
- Ovarian tissue transplantation, Cryopreserved ovarian tissue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orthotopic graftProcedure or surgery
Also called ovarian tissue autotransplantation
(1) laparoscopy (2) ovarian fragments can be put back inside the pelvic cavity close to the natural location of the ovaries or
heterotopic graftProcedure or surgery
- put under the skin
- the ovarian fragments can be put under the skin of the abdomen
| Study group | Role | What they receive |
|---|---|---|
| 1- orthotopic graft | Experimental | Not described Receives: Procedure: orthotopic graft |
| 2- heterotopic graft | Experimental | Not described Receives: Procedure: heterotopic graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biological (FSH, LH, E2 and AMH) changes from graft until the revovery of ovarian function
FSH, LH, E2 and AMH follow up every month after graft until the recovery of ovarian function, up to 18 months
Measured: every month after graft, up to 18 months
Radiological (ultrasonography and MRI) changes in ovarian imaging from graft until the revovery of ovarian function
Radiological (only ultrasonography the first 3 months and after ultrasonography and MRI) follow up every month after graft until the recovery of ovarian function, up to 18 months
Measured: every month after graft, up to 18 months
Secondary outcomes (4)
Graft vascularization
Measured: every month up to 18 months
Relapse of the pathology
Measured: every month up to 18 months
Delay and quality of the ovarian function recovery between ortho and heterotopic graft
Measured: after ovarian function recovery, up to 18 months
Number of ovarian fragments necessary for ovarian function recovery
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startJun 2010
- Primary completionJan 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ovarian Tissue TransplantationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Agence de La Biomédecine
- Responsible party
- Sponsor
- Investigators
- Poirot Catherine, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02184806
- Sponsor's protocol ID
- P080802
- Acronym
- CAROLéLISA
- Status last verified
- Oct 2017
- First submitted
- 13 Jun 2014
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Vatel M, Torre A, Paillusson B, Scheffler F, Bergere M, Benkhalifa M, Le Martelot MT, Leperlier F, Mirallie S, Selleret L, Prades-Borio M, Neuraz A, Barraud-Lange V, Boissel N, Fortin A, Poirot C. Efficacy of assisted reproductive technology after ovarian tissue transplantation in a cohort of 11 patients with or without associated infertility factors. J Assist Reprod Genet. 2021 Feb;38(2):503-511. doi: 10.1007/s10815-020-02033-9. Epub 2021 Jan 3.
PubMed 33389379Poirot C, Fortin A, Lacorte JM, Akakpo JP, Genestie C, Vernant JP, Brice P, Morice P, Leblanc T, Gabarre J, Delmer A, Badachi Y, Drouineaud V, Gouy S, Chalas C, Egels S, Dhedin N, Touraine P, Dommergues M, Lebegue G, Wolf JP, Capron F, Lefebvre G, Boissel N; CAROLeLISA Cooperative Group. Impact of cancer chemotherapy before ovarian cortex cryopreservation on ovarian tissue transplantation. Hum Reprod. 2019 Jun 4;34(6):1083-1094. doi: 10.1093/humrep/dez047.
PubMed 31116405
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autograft of Human Ovarian Tissue: Efficiency and Safety Evaluation
- ClinicalTrials.gov ID
- NCT02184806
- Acronym / sponsor ID
- CAROLéLISA / P080802
- Conditions
- Ovarian Tissue Transplantation
- Keywords
- Ovarian tissue transplantation, Cryopreserved ovarian tissue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Agence de La Biomédecine
- Study start
- Jun 2010
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 9 Jul 2014 (estimated)
- 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.
Ovarian tissue cryopreservation is a new technique for female fertility preservation. One way to restore fertility is autotransplantation of ovarian tissue.
The principal purpose of this study will be to evaluate the efficiency and safety of this procedure.
Detailed description
Ovarian tissue cryopreservation is a new technique for female fertility preservation before gonadotoxic treatments. The first ovarian tissue cryopreservations were performed 10 years ago. There are two main methods to use frozen ovarian cortex: autograft of ovarian fragments and in vitro follicular growth. At the present time, none mature oocytes were obtained after culture. Since 2000, around twenty publications stating autografts of ovarian cortex reported 8 pregnancy and 6 life birth of healthy babies.
Since 1998 until 2008, in the unit of reproduction biology of pitie-salpetriere hospital in Paris, France, 330 patients have had an ovarian tissue cryopreservation for fertility preservation before gonadotoxic treatment. Among them, at the present time, 180 have a procreative age and in consequence, could ask for the use of their ovarian cortex.
The general aim of this protocol will be to propose to women wishing to have a baby, an ovarian tissue transplantation if the patients have an premature ovarian failure.
The principal aim of this study will be to evaluate the efficiency and the safety of ovarian transplantation.
Before grafting, the absence of contra- indication will be check. An informed consent will be signed by the patient. Autograft of ovarian cortex will be performed either in orthotopic or in heterotopic localization according to the pathology and a possible contra-indication to orthotopic position.
After graft, each month hormonal assessment, ovarian echography and, after 3 months, an MRI, will be performed.
Assisted Reproductive Technologies (ART) will be performed in case of heterotopic graft and if necessary in case of orthotopic graft.
The efficiency of ovarian tissue autograft will be appreciated by the delay before the recovery of the ovarian function, the oocyte and embryos qualities in case of ART.
Finally, the number of pregnancies and live births will be also appreciated as well as a possible recurrence of the pathology.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1- orthotopic graft | Experimental | Procedure: orthotopic graft |
| 2- heterotopic graft | Experimental | Procedure: heterotopic graft |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- adult women (age ≥ 18 years old) who stored ovarian fragments before gonadotoxic treatments
- Women who desire to conceive
- Married women or in stable couple
- Cured women or in remission
- Women suffering of Premature ovarian failure
Key exclusion criteria (7 listed)
- age < 18 years
- women with normal ovarian function
- women with a disease at high risk for ovarian metastasis
- women with contraindication for surgery
- women with contraindication for pregnancy
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 |
|---|---|---|
| orthotopic graftAlso: ovarian tissue autotransplantation(1) laparoscopy (2) ovarian fragments can be put back inside the pelvic cavity close to the natural location of the ovaries or | Procedure or surgery | 1- orthotopic graft |
| heterotopic graft1. put under the skin 2. the ovarian fragments can be put under the skin of the abdomen | Procedure or surgery | 2- heterotopic graft |
Primary outcome
Biological (FSH, LH, E2 and AMH) changes from graft until the revovery of ovarian function
Time frame: every month after graft, up to 18 months
FSH, LH, E2 and AMH follow up every month after graft until the recovery of ovarian function, up to 18 months
Radiological (ultrasonography and MRI) changes in ovarian imaging from graft until the revovery of ovarian function
Time frame: every month after graft, up to 18 months
Radiological (only ultrasonography the first 3 months and after ultrasonography and MRI) follow up every month after graft until the recovery of ovarian function, up to 18 months
4 secondary outcomes
Graft vascularization
Time frame: every month up to 18 months
Relapse of the pathology
Time frame: every month up to 18 months
Delay and quality of the ovarian function recovery between ortho and heterotopic graft
Time frame: after ovarian function recovery, up to 18 months
Number of ovarian fragments necessary for ovarian function recovery
Time frame: up to 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Derived from this study: PubMed 33389379Vatel M, Torre A, Paillusson B, Scheffler F, Bergere M, Benkhalifa M, Le Martelot MT, Leperlier F, Mirallie S, Selleret L, Prades-Borio M, Neuraz A, Barraud-Lange V, Boissel N, Fortin A, Poirot C. Efficacy of assisted reproductive technology after ovarian tissue transplantation in a cohort of 11 patients with or without associated infertility factors. J Assist Reprod Genet. 2021 Feb;38(2):503-511. doi: 10.1007/s10815-020-02033-9. Epub 2021 Jan 3.
- Derived from this study: PubMed 31116405Poirot C, Fortin A, Lacorte JM, Akakpo JP, Genestie C, Vernant JP, Brice P, Morice P, Leblanc T, Gabarre J, Delmer A, Badachi Y, Drouineaud V, Gouy S, Chalas C, Egels S, Dhedin N, Touraine P, Dommergues M, Lebegue G, Wolf JP, Capron F, Lefebvre G, Boissel N; CAROLeLISA Cooperative Group. Impact of cancer chemotherapy before ovarian cortex cryopreservation on ovarian tissue transplantation. Hum Reprod. 2019 Jun 4;34(6):1083-1094. doi: 10.1093/humrep/dez047.
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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.
Poirot Catherine, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing orthotopic graft and heterotopic graft in people with Ovarian Tissue Transplantation, run by Assistance Publique - Hôpitaux de Paris 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 7 inclusion and 7 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 6 Nov 2017. 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 Poirot Catherine, MD, PhD (+33 1 56 01 78 00, Catherine.poirot@tnn.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biological (FSH, LH, E2 and AMH) changes from graft until the revovery of ovarian function (time frame: every month after graft, up to 18 months). The study lists 2 primary outcomes in all. 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 NCT02184806, which also lists 2 linked publications.
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 6 Nov 2017.