Constitution of a Cohort for Monitoring Patients Candidating for Ovarian Tissue Autograft

NCT02855827 | Recruiting

• 1 other identifier: P/2013/170
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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 build a cohort of patients likely to use their ovarian tissue cryopreserved by autograft.

Conditions

Ovarian Function Insufficiency

Outcome Measures

Primary Outcomes (1)

• Number of patient who are candidate to ovarian tissue autograft

  5 years

Eligibility Criteria

• Age: 11 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

patients likely to re-use their ovarian tissue cryopreserved by autograft

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead
• CHU de Reims: collaborator
• University Hospital, Marseille: collaborator
• University Hospital, Lille: collaborator
• Central Hospital, Nancy, France: collaborator
• University Hospital, Grenoble: collaborator
• CMCO SIHCUS, Schiltingheim: collaborator
• University Hospital, Bordeaux: collaborator
• Nantes University Hospital: collaborator
• University Hospital, Limoges: collaborator

Study Sites (1)

CHRU Besancon

Besançon, 25030, France

RECRUITING

Related Publications (3)

• 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.

  PMID: 20117783 BACKGROUND

• 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.

  PMID: 23633552 BACKGROUND

• 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.

  PMID: 17307173 BACKGROUND

Central Study Contacts

Chlotilde AMIOT, MD, PhD

CONTACT

camiot@chu-besancon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2016
• First Posted: August 4, 2016
• Study Start: May 1, 2013
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: July 12, 2024

Record last verified: 2024-06

Locations

FR (1)