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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02454829
Other study ID # CRYOFONOV01
Secondary ID
Status Completed
Phase N/A
First received April 22, 2015
Last updated April 14, 2016
Start date March 2015
Est. completion date January 2016

Study information

Verified date April 2016
Source Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 546
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- deceased women in this cohort

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Belgium Cliniques Universitaires Saint Luc Brussels

Sponsors (1)

Lead Sponsor Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Persistence of ovarian function 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) No
Secondary Satisfaction with the undergone 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) No
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