NCT02454829

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
546

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 27, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

April 15, 2016

Status Verified

April 1, 2016

Enrollment Period

10 months

First QC Date

April 22, 2015

Last Update Submit

April 14, 2016

Conditions

Female Infertility

Keywords

Ovarian cortex cryopreservationovarian function

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (1)

  • Satisfaction with the undergone cryopreservation procedure

    at the time of completion of the questionnaire (24 up to 216 months after the cryopreservation procedure)

Study Arms (6)

Adults, gonadotoxic treatment

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

Other: questionnaire

Girls, gonadotoxic treatment

Girls under 18 years of age who underwent ovarian cortex cryopreservation before gonadotoxic treatment (chemotherapy, radiotherapy)

Other: questionnaire

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

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

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

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

Interventions

questionnaireOTHER

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 disordersAdults, gonadotoxic treatmentAdults, ovarian pathologyGirls, genetic disordersGirls, gonadotoxic treatmentGirls, ovarian pathology

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • deceased women in this cohort

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques Universitaires Saint Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Infertility, Female

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Pascale Jadoul

    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2015

First Posted

May 27, 2015

Study Start

March 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

April 15, 2016

Record last verified: 2016-04

Locations

BE(1)