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

Female Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02454829
• Other study ID #: CRYOFONOV01
• 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

• Female Infertility
• Infertility, Female

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