Menu
Recruiting NCT02878434

Fertility Preservation in Young Women With Cancer

Observational Cancer Fertility

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cancer, Fertility. Basic parameters: 0 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium, Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Fertility Outcome [Time frame: 10 years]
Secondary outcome measures (1)
  • Oncological Outcome [Time frame: 5 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Belgium · 1 center
  • UZ Gasthuisberg, Katholieke Universiteit Leuven — Leuven
Netherlands · 1 center
  • The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital — Amsterdam

Identifiers

NCT: NCT02878434 · INCIP Fer

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗