Fertility Preservation in Young Women With Cancer

Cancer Clinical Trial

Official title:

Fertility Preservation in Young Women With Cancer: an International Registration Study From the International Network on Cancer, Infertility and Pregnancy (INCIP)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02878434
• Other study ID #: INCIP Fer
• Status: Recruiting
• Start date: May 23, 2017
• Est. completion date: July 2032

Study information

• Verified date: November 2020
• Source: University Hospital, Gasthuisberg
• Contact: Katrien Van Tornout
• Phone: +3216342876
• Email: katrien.vantornout[@]uzleuven.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: July 2032
• Est. primary completion date: July 2032
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Fertility

Locations

Country	Name	City	State
Belgium	UZ Gasthuisberg, Katholieke Universiteit Leuven	Leuven
Netherlands	The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital	Amsterdam

Sponsors (7)

Lead Sponsor	Collaborator
University Hospital, Gasthuisberg	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano, Haukeland University Hospital, Medical University of Vienna, N.N. Blokchin NMRCO, NKI-AvL, Oslo University Hospital

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fertility Outcome	pregnancy rate	10 years
Secondary	Oncological Outcome	Recurrence of cancer	5 years

External Links

•   This site provides background information on the problem of cancer in pregnancy and cancer and fertility