CancerNCT02878434
Fertility Preservation in Young Women With Cancer
An observational study of Cancer and Fertility, run by University Hospital, Gasthuisberg at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 0 to 40 years, women only
- How many people
- 2,000 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 23 May 2017to Jul 2032
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: All women diagnosed with cancer for whom a fertility preserving cancer treatment is applied will be considered for inclusion.
Who may be able to join
- 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.
Who cannot join
- Mentally disabled or significantly altered mental status that would prohibit the understanding and giving of informed consent
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Belgium1 site, 1 recruiting
- Recruiting
UZ Gasthuisberg, Katholieke Universiteit Leuven
Leuven, 3000
Katrien Van Tornout, +3216342876, katrien.vantornout@uzleuven.be
Frédéric Amant, MD, PhD
Netherlands1 site, 1 recruiting
- Recruiting
The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam
Christianne Lok, MD, PhD, c.lok@nki.nl
Christianne Lok, MD, PhD
About this study
Official title: Fertility Preservation in Young Women With Cancer: an International Registration Study From the International Network on Cancer, Infertility and Pregnancy (INCIP)
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.
Read the 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.
- Keywords
- Cancer, Fertility, Pregnancy, Chemotherapy, Radiotherapy, Long term, Follow up
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Not described | |
| control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fertility Outcome
pregnancy rate
Measured: 10 years
Secondary outcomes (1)
Oncological Outcome
Recurrence of cancer
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study start23 May 2017
- Primary completionJul 2032 (estimated)
- Study completionJul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Gasthuisberg
- Sponsor type
- University, hospital or other
- Collaborators
- The Netherlands Cancer Institute, Medical University of Vienna, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Oslo University Hospital, Haukeland University Hospital, N.N. Blokchin NMRCO
- Responsible party
- Principal investigator, Frederic Amant, University Hospital, Gasthuisberg
- Investigators
- Frédéric Amant, MD, PhD, Principal investigator, UZ Gasthuisberg & KU Leuven, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02878434
- Sponsor's protocol ID
- INCIP Fer
- Status last verified
- Nov 2020
- First submitted
- 22 Aug 2016
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fertility Preservation in Young Women With Cancer: an International Registration Study From the International Network on Cancer, Infertility and Pregnancy (INCIP)
- ClinicalTrials.gov ID
- NCT02878434
- Acronym / sponsor ID
- INCIP Fer
- Keywords
- Cancer, Fertility, Pregnancy, Chemotherapy, Radiotherapy, Long term, Follow up
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University Hospital, GasthuisbergUniversity, hospital or other
- Collaborators
- The Netherlands Cancer Institute, Medical University of Vienna, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Oslo University Hospital, Haukeland University Hospital, N.N. Blokchin NMRCO
- Study start
- 23 May 2017 (actual)
- Primary completion
- Jul 2032 (estimated)
- Study completion
- Jul 2032 (estimated)
- First posted
- 25 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | – |
| control group | – | – |
Who may qualify
- Ages
- 0 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All women diagnosed with cancer for whom a fertility preserving cancer treatment is applied will be considered for inclusion.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Mentally disabled or significantly altered mental status that would prohibit the understanding and giving of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fertility Outcome
Time frame: 10 years
pregnancy rate
1 secondary outcome
Oncological Outcome
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
- This site provides background information on the problem of cancer in pregnancy and cancer and fertilityLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Frédéric Amant, MD, PhD principal investigator
UZ Gasthuisberg & KU Leuven, Belgium
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Fertility, run by University Hospital, Gasthuisberg at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katrien Van Tornout (+3216342876, katrien.vantornout@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fertility Outcome (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2020; AzTrials last refreshed its copy on 8 Nov 2026.