Fertility Preservation in Young Women With Cancer

Recruiting

• Conditions: Cancer; Fertility

• Registration Number: NCT02878434
• Lead Sponsor: University Hospital, Gasthuisberg

Brief Summary

The researchers aim to record the incidence, treatment and long term follow up of fertility preserving cancer treatment. Both the oncological and fertility outcome are recorded.

Study population: All patients with a cancer for whom a fertility preserving cancer treatment is applied. The results of the study population are compared to young women undergoing standard cancer treatment.

Detailed Description

Cancer is the second leading cause of death during the reproductive years. The long term survival improves for most cancers, reaching 80% for pediatric cancer and more than 70% for cancers in adults between 20 and 49 years of age. Early detection and improvements in cancer treatment contribute to these figures. As a result, quality of life of which preservation of fertility is one aspect, becomes more important. Fertility may however be influenced by surgery and by the gonadotoxic effects of chemo and/or radiotherapy. Therefore, fertility sparing treatments are offered to young patients in order to maintain the wish to conceive after cancer treatment. This however is associated with deviation of standard treatment and many different strategies are applied among different centers. In addition, there is a lack of studies investigating the oncological safety of these fertility sparing treatment protocols. The results of this study will enable us to better inform clinicians and patients on the efficacy of fertility sparing cancer treatment.

Objective:

To record the incidence, treatment and long term follow up of fertility preserving cancer treatment. Both the oncological and fertility outcome are recorded.

Study design: International multicentre prospective observational trial

Study population: All patients with a cancer for whom a fertility preserving cancer treatment is applied. The results of the study population are compared to young women undergoing standard cancer treatment.

Main study parameters/endpoints:

Registration of cancer diagnosis, treatment and outcome. Both the oncologic and fertility outcome is registered.

All patients receive fertility sparing cancer treatment on their specific request.

Study Timeline

• Study First Submitted: 2016-08-22
• Study First Submitted QC: 2016-08-22
• Study First Posted: 2016-08-25
• Study Start: 2017-05-23
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-17
• Last Update Posted: 2020-11-18
• Primary Completion: 2032-07
• Study Completion: 2032-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 2000

Inclusion Criteria

• Young women who want to preserve their fertility during cancer treatment. Patients need to give their signed and written informed consent to participate in the study.

Exclusion Criteria

• Mentally disabled or significantly altered mental status that would prohibit the understanding and giving of informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fertility Outcome	10 years	pregnancy rate

Secondary Outcome Measures

Name	Time	Method
Oncological Outcome	5 years	Recurrence of cancer

Trial Locations

Locations (2)

The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital; 🇳🇱 Amsterdam, Netherlands

UZ Gasthuisberg, Katholieke Universiteit Leuven; 🇧🇪 Leuven, Belgium