Ovarian Function InsufficiencyPERIDATORNCT02855827
Constitution of a Cohort for Monitoring Patients Candidating for Ovarian Tissue Autograft
An observational study of 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 11 to 43 years, women only
- Conditions the study is for
- Ovarian Function Insufficiency
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- May 2013to Oct 2025
- Phase
- Observational
- 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 11 to 43 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: patients likely to re-use their ovarian tissue cryopreserved by autograft
Who may be able to join
- Patients who have cryopreserved their ovarian tissue;
- Patients with premature ovarian insufficiency;
- Patients older than 11 years (bone age) for induction of puberty;
- Patients aged from 18 to 43 years for the restoration of ovarian function;
- No objection from the patient
- Patients who have already received ovarian tissue autograft.
Who cannot join
- Patients aged under 11 years (bone age);
- Patients older than 43 years;
- Patients refusing to be included;
- Patients (adults) under guardianship, curators and safeguard justice
Trial locations and contacts
1 site in 1 country.
Chlotilde AMIOT, MD, PhD contact
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 build a cohort of patients likely to use their ovarian tissue cryopreserved by autograft.
Read the detailed description
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 build a cohort of patients likely to use their ovarian tissue cryopreserved by autograft. This cohort will be used to:
- Follow up of patients with their cryopreserved ovarian tissue;
- Evaluate requests for ovarian tissue grafting ;
- Propose a search of residual disease in case of neoplastic disease risk (if possible);
- Allowing patients to benefit from an ovarian tissue autograft;
- Assess the effectiveness of autograft technique after the restoration of ovarian function.
- Conditions
- Ovarian Function Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patient who are candidate to ovarian tissue autograft
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 posted4 Aug 2016 (estimated)
- Study startMay 2013
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 240 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, University Hospital, Lille, Central Hospital, Nancy, France, University Hospital, Grenoble, CMCO SIHCUS, Schiltingheim, University Hospital, Bordeaux, Nantes University Hospital, University Hospital, Limoges
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02855827
- Sponsor's protocol ID
- P/2013/170
- Acronym
- PERIDATOR
- Status last verified
- Jun 2024
- First submitted
- 20 Jul 2016
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
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 17307173
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
- Constitution of a Cohort for Monitoring Patients Candidating for Ovarian Tissue Autograft
- ClinicalTrials.gov ID
- NCT02855827
- Acronym / sponsor ID
- PERIDATOR / P/2013/170
- Conditions
- Ovarian Function Insufficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- CHU de Reims, University Hospital, Marseille, University Hospital, Lille, Central Hospital, Nancy, France, University Hospital, Grenoble, CMCO SIHCUS, Schiltingheim, University Hospital, Bordeaux, Nantes University Hospital, University Hospital, Limoges
- Study start
- May 2013 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 4 Aug 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 build a cohort of patients likely to use their ovarian tissue cryopreserved by autograft.
Detailed description
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 build a cohort of patients likely to use their ovarian tissue cryopreserved by autograft. This cohort will be used to:
- Follow up of patients with their cryopreserved ovarian tissue;
- Evaluate requests for ovarian tissue grafting ;
- Propose a search of residual disease in case of neoplastic disease risk (if possible);
- Allowing patients to benefit from an ovarian tissue autograft;
- Assess the effectiveness of autograft technique after the restoration of ovarian function.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 11 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- patients likely to re-use their ovarian tissue cryopreserved by autograft
Key inclusion criteria (6 listed)
- Patients who have cryopreserved their ovarian tissue;
- Patients with premature ovarian insufficiency;
- Patients older than 11 years (bone age) for induction of puberty;
- Patients aged from 18 to 43 years for the restoration of ovarian function;
- No objection from the patient
Key exclusion criteria (4 listed)
- Patients aged under 11 years (bone age);
- Patients older than 43 years;
- Patients refusing to be included;
- Patients (adults) under guardianship, curators and safeguard justice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patient who are candidate to ovarian tissue autograft
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.
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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.
Chlotilde AMIOT, MD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 6 inclusion and 4 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 Chlotilde AMIOT, MD, PhD (camiot@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patient who are candidate to ovarian tissue autograft (time frame: 5 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 NCT02855827, which also lists 3 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.