Autograft of Human Ovarian Tissue : Efficiency and Safety (CAROLéLISA)

November 3, 2017 updated by: Assistance Publique - Hôpitaux de Paris

Autograft of Human Ovarian Tissue: Efficiency and Safety Evaluation

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Ovarian tissue cryopreservation is a new technique for female fertility preservation before gonadotoxic treatments. The first ovarian tissue cryopreservations were performed 10 years ago. There are two main methods to use frozen ovarian cortex: autograft of ovarian fragments and in vitro follicular growth. At the present time, none mature oocytes were obtained after culture. Since 2000, around twenty publications stating autografts of ovarian cortex reported 8 pregnancy and 6 life birth of healthy babies.

Since 1998 until 2008, in the unit of reproduction biology of pitie-salpetriere hospital in Paris, France, 330 patients have had an ovarian tissue cryopreservation for fertility preservation before gonadotoxic treatment. Among them, at the present time, 180 have a procreative age and in consequence, could ask for the use of their ovarian cortex.

The general aim of this protocol will be to propose to women wishing to have a baby, an ovarian tissue transplantation if the patients have an premature ovarian failure.

The principal aim of this study will be to evaluate the efficiency and the safety of ovarian transplantation.

Before grafting, the absence of contra- indication will be check. An informed consent will be signed by the patient. Autograft of ovarian cortex will be performed either in orthotopic or in heterotopic localization according to the pathology and a possible contra-indication to orthotopic position.

After graft, each month hormonal assessment, ovarian echography and, after 3 months, an MRI, will be performed.

Assisted Reproductive Technologies (ART) will be performed in case of heterotopic graft and if necessary in case of orthotopic graft.

The efficiency of ovarian tissue autograft will be appreciated by the delay before the recovery of the ovarian function, the oocyte and embryos qualities in case of ART.

Finally, the number of pregnancies and live births will be also appreciated as well as a possible recurrence of the pathology.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75020
        • Recruiting
        • Hôpital Tenon, service de Biologie de la reproduction
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion criteria :

  • 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

Exclusion criteria :

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1- orthotopic graft
Procedure: orthotopic graft
(1) laparoscopy (2) ovarian fragments can be put back inside the pelvic cavity close to the natural location of the ovaries or
Other Names:
  • ovarian tissue autotransplantation
Experimental: 2- heterotopic graft
Procedure: heterotopic graft
  1. put under the skin
  2. the ovarian fragments can be put under the skin of the abdomen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biological (FSH, LH, E2 and AMH) changes from graft until the revovery of ovarian function
Time Frame: every month after graft, up to 18 months
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
Time Frame: every month after graft, up to 18 months
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 Outcome Measures

Outcome Measure
Time Frame
Graft vascularization
Time Frame: every month up to 18 months
every month up to 18 months
Relapse of the pathology
Time Frame: every month up to 18 months
every month up to 18 months
Delay and quality of the ovarian function recovery between ortho and heterotopic graft
Time Frame: after ovarian function recovery, up to 18 months
after ovarian function recovery, up to 18 months
Number of ovarian fragments necessary for ovarian function recovery
Time Frame: up to 18 months
up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Agence de La Biomédecine

Investigators

  • Principal Investigator: Poirot Catherine, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

June 13, 2014

First Submitted That Met QC Criteria

July 3, 2014

First Posted (Estimate)

July 9, 2014

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

November 3, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • P080802

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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