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RecruitingNCT02846064DATORUpdated Jul 12, 2024

Development of Ovarian Tissue Autograft in Order to Restore Ovarian Function

An interventional study of Autograft of cryopreserved ovarian tissue in Ovarian Function Insufficiency, sponsored by Centre Hospitalier Universitaire de Besancon. Recruiting at 1 site in France. Open to female participants aged 18 Years to 43 Years. Per ClinicalTrials.gov, last updated 2024-07-12.

Sponsored by Centre Hospitalier Universitaire de Besancon · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 43 Years
Sex
Female
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Study 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. 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.

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Conditions studied

  • Ovarian Function Insufficiency
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In context

Lead sponsor

Centre Hospitalier Universitaire de Besancon is the lead sponsor of 439 studies on the registry; 97 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 43 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Patients under trusteeship
  • Patients placed in receivers
  • Patients under the protection of a conservator
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Other
    Ovarian tissue cryopreservation

    Procedure: Autograft of cryopreserved ovarian tissue

Interventions

  • ProcedureAutograft of cryopreserved ovarian tissue

    Orthotopic transplantation

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What researchers measure

Primary outcomes

  1. Restoration of ovarian function by using autograft

    Time frame: 2 years

Secondary outcomes

  1. Number of live births after ovarian tissue autograft

    Time frame: 5 years

  2. Number of complications that could result from a surgery with anesthesia or depending on graft quality

    Time frame: 5 years

  3. Number of graft recovery

    Time frame: 5 years

  4. Number of residual disease development.

    Time frame: 5 years

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Study locations

1 of 1 sites recruiting
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References and documents

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 20117783 ↗
  • Amiot 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 23633552 ↗
  • Fauque 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 ↗
  • Pretalli 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02846064
Lead sponsor
Centre Hospitalier Universitaire de Besancon
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
First posted
Jul 27, 2016
Start date
Oct 2013
Primary completion
Dec 31, 2023
Completion
Dec 31, 2024 (estimated)
Last update
Jul 12, 2024

Study contacts

Clotilde AMIOT, MD PhD
Contact
clotilde.amiot@univ-fcomte.fr
+33381218681

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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