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

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.

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Key information

Conditions

Female Infertility Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Infertility, Female Urogenital Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Cliniques Universitaires Saint Luc

Brussels, 1200, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

deceased women in this cohort

Treatment and study plan

Questionnaire

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.

Primary outcomes

Persistence of ovarian function

Time frame: 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 outcomes

Satisfaction with the undergone cryopreservation procedure

Time frame: 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

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study 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

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: May 27, 2015
Registry last updated: Apr 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed