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NCT Number: NCT02878434

Fertility Preservation in Young Women With Cancer

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.

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Key information

Conditions

Cancer Fertility Neoplasms

Age range

0 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

UZ Gasthuisberg, Katholieke Universiteit Leuven, Leuven, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Fertility Outcome

    Time frame: 10 years

    pregnancy rate

Secondary outcomes

  1. Oncological Outcome

    Time frame: 5 years

    Recurrence of cancer

Study contacts

Contact information is provided by the study sponsor or research team.

Katrien Van Tornout

CONTACT

[email protected]

+3216342876

Sponsors and collaborators

Lead sponsor

University Hospital, Gasthuisberg

Other

Collaborators

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
  • Haukeland University Hospital
  • Medical University of Vienna
  • N.N. Blokchin NMRCO
  • NKI-AvL
  • Oslo University Hospital

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2032
Study completion
2032
First posted
Aug 25, 2016
Registry last updated
Nov 18, 2020

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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