Follow-up of Ovarian Function in Young Women Who Underwent Ovarian Cortex Cryopreservation

April 14, 2016 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Follow-up of Ovarian Function in Young Girls and Women Who Underwent Ovarian Cortex Cryopreservation for Fertility Preservation at the Cliniques Universitaires Saint-Luc

Evaluation of ovarian function by a questionnaire and by medical file analysis of women and girls who underwent ovarian cortex cryopreservation for fertility preservation between 1997 an 2013 in the investigators' institution in order to evaluate their residual ovarian function. A second part of the questionnaire concerns these women's satisfaction regarding the procedure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Between 1997 and december 2013, 546 girls and women underwent ovarian cortex cryopreservation in the investigators' institution for fertility preservation. The main indications were the need for a gonadotoxic treatment, repeated ovarian surgery and a genetic risk for premature ovarian failure . These women will be sent a questionnaire concerning their ovarian function since the procedure and a questionnaire about their satisfaction concerning the procedure. Six different questionnaires will be used adapted to the patient's initial indication for cryopreservation and the patient's age at the time of cryopreservation. Complementary data will be obtained by medical file analysis and by contacting the patient's family doctor or gynecologist.

Data will be correlated with received gonadotoxic treatment and surgical interventions.

The purpose of the study is to improve the indications and patient selection for ovarian cortex cryopreservation.

Study Type

Observational

Enrollment (Actual)

546

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

  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint Luc

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

All women who underwent ovarian cortex cryopreservation in our institution between 1997 and 2013

Description

Inclusion Criteria:

  • women who underwent ovarian cortex cryopreservation in our institution between 1997 and 2013

Exclusion Criteria:

  • deceased women in this cohort

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adults, gonadotoxic treatment
Women 18 years of age or older who underwent ovarian cortex cryopreservation before gonadotoxic treatment (chemotherapy, radiotherapy)
Other: questionnaire
A questionnaire will be send concerning the patient's ovarian function since the cryopreservation procedure i.e: progression of puberty, menstrual cycle, hormonal treatment, desire for pregnancy, occurence of pregnancy, details of pregnancy, need for ART (Artificial Reproductive Techniques), and about the patient's satisfaction concerning the cryopreservation procedure. Data collected will be correlated with treatments received.
Girls, gonadotoxic treatment
Girls under 18 years of age who underwent ovarian cortex cryopreservation before gonadotoxic treatment (chemotherapy, radiotherapy)
Other: questionnaire
A questionnaire will be send concerning the patient's ovarian function since the cryopreservation procedure i.e: progression of puberty, menstrual cycle, hormonal treatment, desire for pregnancy, occurence of pregnancy, details of pregnancy, need for ART (Artificial Reproductive Techniques), and about the patient's satisfaction concerning the cryopreservation procedure. Data collected will be correlated with treatments received.
Adults, ovarian pathology
Women 18 years of age or older who underwent ovarian cortex cryopreservation for an ovarian pathology not requiring gonadotoxic treatment but surgery
Other: questionnaire
A questionnaire will be send concerning the patient's ovarian function since the cryopreservation procedure i.e: progression of puberty, menstrual cycle, hormonal treatment, desire for pregnancy, occurence of pregnancy, details of pregnancy, need for ART (Artificial Reproductive Techniques), and about the patient's satisfaction concerning the cryopreservation procedure. Data collected will be correlated with treatments received.
Girls, ovarian pathology
Girls under 18 years of age who underwent ovarian cortex cryopreservation for an ovarian pathology not requiring gonadotoxic treatment but surgery
Other: questionnaire
A questionnaire will be send concerning the patient's ovarian function since the cryopreservation procedure i.e: progression of puberty, menstrual cycle, hormonal treatment, desire for pregnancy, occurence of pregnancy, details of pregnancy, need for ART (Artificial Reproductive Techniques), and about the patient's satisfaction concerning the cryopreservation procedure. Data collected will be correlated with treatments received.
Adults, genetic disorders
Women 18 years of age or older who underwent ovarian cortex cryopreservation in the context of a genetic risk of premature ovarian failure
Other: questionnaire
A questionnaire will be send concerning the patient's ovarian function since the cryopreservation procedure i.e: progression of puberty, menstrual cycle, hormonal treatment, desire for pregnancy, occurence of pregnancy, details of pregnancy, need for ART (Artificial Reproductive Techniques), and about the patient's satisfaction concerning the cryopreservation procedure. Data collected will be correlated with treatments received.
Girls, genetic disorders
Girls under 18 years of age who underwent ovarian cortex cryopreservation in the context of a genetic risk of premature ovarian failure
Other: questionnaire
A questionnaire will be send concerning the patient's ovarian function since the cryopreservation procedure i.e: progression of puberty, menstrual cycle, hormonal treatment, desire for pregnancy, occurence of pregnancy, details of pregnancy, need for ART (Artificial Reproductive Techniques), and about the patient's satisfaction concerning the cryopreservation procedure. Data collected will be correlated with treatments received.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Persistence of ovarian function
Time Frame: since the cryopreservation procedure (24 up to 216 months)
Prove of ovarian function will be the occurence of pregnancy, the presence of menstrual cycles without hormonal treatment based on the questionnaire or on biological findings compatible with ovarian function in medical file
since the cryopreservation procedure (24 up to 216 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction with the undergone cryopreservation procedure
Time Frame: at the time of completion of the questionnaire (24 up to 216 months after the cryopreservation procedure)
The questionnaire will evaluate the patient's satisfaction concerning the cryopreservation procedure
at the time of completion of the questionnaire (24 up to 216 months after the cryopreservation procedure)

Collaborators and Investigators

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

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

  • Principal Investigator: Pascale Jadoul, Cliniques Universitaires Saint-Luc

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

March 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

April 22, 2015

First Submitted That Met QC Criteria

May 26, 2015

First Posted (Estimate)

May 27, 2015

Study Record Updates

Last Update Posted (Estimate)

April 15, 2016

Last Update Submitted That Met QC Criteria

April 14, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRYOFONOV01

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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