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

NCT ID: NCT02454829

Last Updated: 2016-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

546 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Female Infertility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adults, gonadotoxic treatment

Women 18 years of age or older who underwent ovarian cortex cryopreservation before gonadotoxic treatment (chemotherapy, radiotherapy)

questionnaire

Intervention Type OTHER

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)

questionnaire

Intervention Type OTHER

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

questionnaire

Intervention Type OTHER

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

questionnaire

Intervention Type OTHER

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

questionnaire

Intervention Type OTHER

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

questionnaire

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* deceased women in this cohort
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pascale Jadoul

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Locations

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Cliniques Universitaires Saint Luc

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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CRYOFONOV01

Identifier Type: -

Identifier Source: org_study_id

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