Ovarian Function InsufficiencyDATORNCT02846064
Development of Ovarian Tissue Autograft in Order to Restore Ovarian Function
A study testing Autograft of cryopreserved ovarian tissue in people with Ovarian Function Insufficiency, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
Ovarian cryopreservation is one of the available option for preserving fertility prior to potentially sterilizing treatments. In the absence of other techniques such as in vitro folliculogenesis or injection of isolated ovarian follicles, this tissue can only be re-used by autograft. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Ovarian Function Insufficiency
- What is being tested?
- Autograft of cryopreserved ovarian tissue
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to 31 Dec 2024
- 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 43 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients who underwent Ovarian tissue cryopreservation
- Premature ovarian failure
- Patients cured of their primary disease
- Women between 18 and 43 years of age
- Patients who have already benefited from ovarian tissue autograft
Who cannot join
- Patients under trusteeship
- Patients placed in receivers
- Patients under the protection of a conservator
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHRU Besancon
Besançon, 25030
Clotilde AMIOT, PhD, MD, +33 3 81 21 86 81, clotilde.amiot@univ-fcomte.fr
About this study
Ovarian cryopreservation is one of the available option for preserving fertility prior to potentially sterilizing treatments. In the absence of other techniques such as in vitro folliculogenesis or injection of isolated ovarian follicles, this tissue can only be re-used by autograft. In France, the first live birth after orthotopic ovarian transplantation, was obtained by Roux et al. in 2009. This clinical trial aims to collect data on the efficiency of the graft in terms of restoration of ovarian function and live births. It will also allow us to carry out the patient follow-up after ovarian tissue cryopreservation and after autograft when achieved. In cases of neoplastic malignancies, minimal residual disease detection will be performed on ovarian tissue, to avoid any risk of cancer re-seeding.
- Conditions
- Ovarian Function Insufficiency
- Being tested
- Autograft of cryopreserved ovarian tissue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autograft of cryopreserved ovarian tissueProcedure or surgery
Orthotopic transplantation
| Study group | Role | What they receive |
|---|---|---|
| Ovarian tissue cryopreservation | Other | Not described Receives: Procedure: Autograft of cryopreserved ovarian tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restoration of ovarian function by using autograft
Measured: 2 years
Secondary outcomes (4)
Number of live births after ovarian tissue autograft
Measured: 5 years
Number of complications that could result from a surgery with anesthesia or depending on graft quality
Measured: 5 years
Number of graft recovery
Measured: 5 years
Number of residual disease development.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startOct 2013
- Primary completion31 Dec 2023
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ovarian Function InsufficiencyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- CHU de Reims, University Hospital, Marseille, Nantes University Hospital, University Hospital, Lille, Central Hospital, Nancy, France, University Hospital, Toulouse, University Hospital, Grenoble, University Hospital, Bordeaux, CMCO SIHCUS, Schiltingheim, University Hospital, Rouen, University Hospital, Limoges, University Hospital, Angers, Centre Hospitalier Universitaire de Nice, Tenon Hospital, Paris, Poissy-Saint Germain Hospital, Hôpital Jean Verdier, University Hospital, Clermont-Ferrand, Hopital Antoine Beclere
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02846064
- Sponsor's protocol ID
- P/2012/143
- Acronym
- DATOR
- Status last verified
- Jun 2024
- First submitted
- 25 Oct 2013
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Roux C, Amiot C, Agnani G, Aubard Y, Rohrlich PS, Piver P. Live birth after ovarian tissue autograft in a patient with sickle cell disease treated by allogeneic bone marrow transplantation. Fertil Steril. 2010 May 1;93(7):2413.e15-9. doi: 10.1016/j.fertnstert.2009.12.022. Epub 2010 Feb 1.
PubMed 20117783Amiot C, Angelot-Delettre F, Zver T, Alvergnas-Vieille M, Saas P, Garnache-Ottou F, Roux C. Minimal residual disease detection of leukemic cells in ovarian cortex by eight-color flow cytometry. Hum Reprod. 2013 Aug;28(8):2157-67. doi: 10.1093/humrep/det126. Epub 2013 Apr 30.
PubMed 23633552Fauque P, Ben Amor A, Joanne C, Agnani G, Bresson JL, Roux C. Use of trypan blue staining to assess the quality of ovarian cryopreservation. Fertil Steril. 2007 May;87(5):1200-7. doi: 10.1016/j.fertnstert.2006.08.115. Epub 2007 Feb 20.
PubMed 17307173Pretalli JB, Frontczak Franck S, Pazart L, Roux C, Amiot C; DATOR Group. Development of Ovarian Tissue Autograft to Restore Ovarian Function: Protocol for a French Multicenter Cohort Study. JMIR Res Protoc. 2019 Sep 30;8(9):e12944. doi: 10.2196/12944.
PubMed 31573931
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Ovarian Tissue Autograft in Order to Restore Ovarian Function
- ClinicalTrials.gov ID
- NCT02846064
- Acronym / sponsor ID
- DATOR / P/2012/143
- Conditions
- Ovarian Function Insufficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- CHU de Reims, University Hospital, Marseille, Nantes University Hospital, University Hospital, Lille, Central Hospital, Nancy, France, University Hospital, Toulouse, University Hospital, Grenoble, University Hospital, Bordeaux, CMCO SIHCUS, Schiltingheim, University Hospital, Rouen, University Hospital, Limoges, University Hospital, Angers, Centre Hospitalier Universitaire de Nice, Tenon Hospital, Paris, Poissy-Saint Germain Hospital, Hôpital Jean Verdier, University Hospital, Clermont-Ferrand, Hopital Antoine Beclere
- Study start
- Oct 2013
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Jul 2016 (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 cryopreservation is one of the available option for preserving fertility prior to potentially sterilizing treatments. In the absence of other techniques such as in vitro folliculogenesis or injection of isolated ovarian follicles, this tissue can only be re-used by autograft. In France, the first live birth after orthotopic ovarian transplantation, was obtained by Roux et al. in 2009. This clinical trial aims to collect data on the efficiency of the graft in terms of restoration of ovarian function and live births. It will also allow us to carry out the patient follow-up after ovarian tissue cryopreservation and after autograft when achieved. In cases of neoplastic malignancies, minimal residual disease detection will be performed on ovarian tissue, to avoid any risk of cancer re-seeding.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ovarian tissue cryopreservation | Other | Procedure: Autograft of cryopreserved ovarian tissue |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients who underwent Ovarian tissue cryopreservation
- Premature ovarian failure
- Patients cured of their primary disease
- Women between 18 and 43 years of age
- Patients who have already benefited from ovarian tissue autograft
Key exclusion criteria (3 listed)
- Patients under trusteeship
- Patients placed in receivers
- Patients under the protection of a conservator
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 |
|---|---|---|
| Autograft of cryopreserved ovarian tissueOrthotopic transplantation | Procedure or surgery | Ovarian tissue cryopreservation |
Primary outcome
Restoration of ovarian function by using autograft
Time frame: 2 years
4 secondary outcomes
Number of live births after ovarian tissue autograft
Time frame: 5 years
Number of complications that could result from a surgery with anesthesia or depending on graft quality
Time frame: 5 years
Number of graft recovery
Time frame: 5 years
Number of residual disease development.
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Background: PubMed 20117783Roux C, Amiot C, Agnani G, Aubard Y, Rohrlich PS, Piver P. Live birth after ovarian tissue autograft in a patient with sickle cell disease treated by allogeneic bone marrow transplantation. Fertil Steril. 2010 May 1;93(7):2413.e15-9. doi: 10.1016/j.fertnstert.2009.12.022. Epub 2010 Feb 1.
- Background: PubMed 23633552Amiot C, Angelot-Delettre F, Zver T, Alvergnas-Vieille M, Saas P, Garnache-Ottou F, Roux C. Minimal residual disease detection of leukemic cells in ovarian cortex by eight-color flow cytometry. Hum Reprod. 2013 Aug;28(8):2157-67. doi: 10.1093/humrep/det126. Epub 2013 Apr 30.
- Background: PubMed 17307173Fauque P, Ben Amor A, Joanne C, Agnani G, Bresson JL, Roux C. Use of trypan blue staining to assess the quality of ovarian cryopreservation. Fertil Steril. 2007 May;87(5):1200-7. doi: 10.1016/j.fertnstert.2006.08.115. Epub 2007 Feb 20.
- Background: PubMed 31573931Pretalli JB, Frontczak Franck S, Pazart L, Roux C, Amiot C; DATOR Group. Development of Ovarian Tissue Autograft to Restore Ovarian Function: Protocol for a French Multicenter Cohort Study. JMIR Res Protoc. 2019 Sep 30;8(9):e12944. doi: 10.2196/12944.
Related trials for Ovarian Function Insufficiency
RecruitingObservational study
Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction, Premature Ovarian Insufficiency and Clinically Indicated Gonadectomy
Turner Syndrome, Post-menarcheal Adolescents
RecruitingObservational study
Effects of Estrogen on Heart Health in Women With Primary Ovarian Insufficiency
Primary Ovarian Insufficiency, Premature Menopause
RecruitingPhase 2/3
Autologous PRP Infusion May Restore Ovarian Function and May Promote Folliculogenesis in POI Patients
Menopause, Premature, Menopause Related Conditions
Active, not recruitingObservational study
Will Autologous Platelet Rich Plasma Able To Restore Ovarian Function?
Infertility, IVF
Not yet recruiting
Clinical Study on the Preservation of Ovarian Function Following Hematopoietic Stem Cell Transplantation in Patients With Malignant Hematologic Diseases Using Goserelin
Allogeneic Haematopoietic Stem Cell Transplantation, Malignant Hematologic Disease
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autograft of cryopreserved ovarian tissue in people with Ovarian Function Insufficiency, run by Centre Hospitalier Universitaire de Besancon 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 5 inclusion and 3 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 2024. 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 Clotilde AMIOT, MD PhD (+33381218681, clotilde.amiot@univ-fcomte.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Restoration of ovarian function by using autograft (time frame: 2 years). 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 NCT02846064, which also lists 4 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 12 Jul 2024.