NCT02184806

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2014

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 9, 2014

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

November 6, 2017

Status Verified

October 1, 2017

Enrollment Period

7.6 years

First QC Date

June 13, 2014

Last Update Submit

November 3, 2017

Conditions

Ovarian Tissue Transplantation

Keywords

Ovarian tissue transplantationCryopreserved ovarian tissue

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    every month after graft, up to 18 months

Secondary Outcomes (4)

  • Graft vascularization

    every month up to 18 months

  • Relapse of the pathology

    every month up to 18 months

  • Delay and quality of the ovarian function recovery between ortho and heterotopic graft

    after ovarian function recovery, up to 18 months

  • Number of ovarian fragments necessary for ovarian function recovery

    up to 18 months

Study Arms (2)

1- orthotopic graft

EXPERIMENTAL
Procedure: orthotopic graft

2- heterotopic graft

EXPERIMENTAL
Procedure: heterotopic graft

Interventions

orthotopic graftPROCEDURE

(1) laparoscopy (2) ovarian fragments can be put back inside the pelvic cavity close to the natural location of the ovaries or

Also known as: ovarian tissue autotransplantation
1- orthotopic graft
heterotopic graftPROCEDURE

1. put under the skin 2. the ovarian fragments can be put under the skin of the abdomen

2- heterotopic graft

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Tenon, service de Biologie de la reproduction

Paris, 75020, France

RECRUITING

Related Publications (2)

  • 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.

    PMID: 33389379DERIVED

  • Poirot 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.

    PMID: 31116405DERIVED

Study Officials

  • Poirot Catherine, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Poirot Catherine, MD, PhD

CONTACT

+33 1 56 01 78 00Catherine.poirot@tnn.aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2014

First Posted

July 9, 2014

Study Start

June 1, 2010

Primary Completion

January 1, 2018

Study Completion

January 1, 2019

Last Updated

November 6, 2017

Record last verified: 2017-10

Locations

FR(1)