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

Completed

• Conditions: Female Infertility
• Interventions: Other: questionnaire

• Registration Number: NCT02454829
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

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 Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-04-22
• Study First Submitted QC: 2015-05-26
• Study First Posted: 2015-05-27
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-14
• Last Update Posted: 2016-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 546

Inclusion Criteria

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

Exclusion Criteria

• deceased women in this cohort

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adults, gonadotoxic treatment	questionnaire	Women 18 years of age or older who underwent ovarian cortex cryopreservation before gonadotoxic treatment (chemotherapy, radiotherapy)
Girls, gonadotoxic treatment	questionnaire	Girls under 18 years of age who underwent ovarian cortex cryopreservation before gonadotoxic treatment (chemotherapy, radiotherapy)
Adults, genetic disorders	questionnaire	Women 18 years of age or older who underwent ovarian cortex cryopreservation in the context of a genetic risk of premature ovarian failure
Adults, ovarian pathology	questionnaire	Women 18 years of age or older who underwent ovarian cortex cryopreservation for an ovarian pathology not requiring gonadotoxic treatment but surgery
Girls, genetic disorders	questionnaire	Girls under 18 years of age who underwent ovarian cortex cryopreservation in the context of a genetic risk of premature ovarian failure
Girls, ovarian pathology	questionnaire	Girls under 18 years of age who underwent ovarian cortex cryopreservation for an ovarian pathology not requiring gonadotoxic treatment but surgery

Primary Outcome Measures

Name	Time	Method
Persistence of ovarian function	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

Secondary Outcome Measures

Name	Time	Method
Satisfaction with the undergone cryopreservation procedure	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

Trial Locations

Locations (1)

Cliniques Universitaires Saint Luc; 🇧🇪 Brussels, Belgium