Condition category
Cancer
Date applied
08/09/2010
Date assigned
06/12/2010
Last edited
30/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Chemotherapy is a type of cancer treatment that can also lead to fertility problems in women of reproductive age. The effects of different types of chemotherapy on fertility are still unknown, and depend on the type of chemotherapy, dosage, duration and the patient's age. Recent studies have found that anti-mullerian hormone (AMH) is a valuable marker of fertility. The aim of this study is to find out about the risks to fertility of chemotherapy drugs and the accuracy of AMH in predicting women's fertility following chemotherapy.

Who can participate?
Women aged 18 - 43 who have been newly diagnosed with cancer (e.g., breast cancer or lymphoma).

What does the study involve?
Blood tests are used to assess AMH levels in cancer patients before chemotherapy and at follow up 6, 9 months and 1 year later, compared with healthy volunteers without known fertility problems of the same age. We hope to follow up patients for at least 5 years to assess their fertility following chemotherapy. A medical questionnaire is completed by all participants, giving their views on the information they received during the study.

What are the possible benefits and risks of participating?
Participants may not directly benefit from taking part in the study, but the results could help with decision-making regarding fertility treatment in the future. Risks of participation include the risks of blood tests.

Where is the study run from?
Warwick University (UK).

When is the study starting and how long is it expected to run for?
May 2010 to November 2011.

Who is funding the study?
Midland Fertility Services Ltd (UK).

Who is the main contact?
Dr Karolina Palinska-Rudzka
K.E.Palinska-Rudzka@warwick.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Karolina Palinska-Rudzka

ORCID ID

Contact details

Centre House
Court Parade Aldridge
Walsall
WS9 8LT
United Kingdom
-
K.E.Palinska-Rudzka@warwick.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

8445

Study information

Scientific title

Effects of chemotherapy upon fertility amongst women of reproductive age, using anti-mullerian hormone (AMH) as a marker of ovarian reserve

Acronym

Study hypothesis

Accurate assessment of reproductive function in women following cancer treatment is increasingly important due to improvements in survival rates and development of new methods of fertility preservation.

Advance counselling regarding chemotherapy's potential to affect future plans for children, premature menopause and offering options for fertility preservation should be a vital, integrated part of care for young women.

Chemotherapy may lead to subfertility and loss of sex hormone production. The effects of different types of chemotherapy on ovarian reserve amongst women of reproductive age are still unknown. Chemotherapy-induced follicle loss is also dependent on the type of chemotherapy, its dosage, duration and age of patient.

Recent studies show that anti-mullerian hormone (AMH) is a valuable marker of ovarian reserve. It is independent of the menstrual cycle and can be accurate and diagnostic even amongst women without regular cycles.

We propose a prospective study to evaluate the risks to fertility of chemotherapeutic regimes and the accuracy of AMH in predicting women's potential reproductive capacity following chemotherapy. The results would be crucial in informing decision-makers and stakeholders regarding fertility treatment prognosis.

Using a prospective cohort design allows us to assess the effect of chemotherapy agents. Although the assays and analysis of AMH will be performed over a shorter period, we hope to followup patients for at least 5 years to begin to assess their post-chemotherapy fertility.
We will recruit 50 to 100 reproductive age women newly diagnosed with cancers, needing chemotherapy within the Cancer Network in West Midlands.

Serum AMH will be measured in patients before commencing chemotherapy and with follow up at 6, 9 months and 1 year compared with an age-matched control group without known fertility problems. 5 year follow-up will be performed.The sponsor of the study is Warwick University, a funder is MFS.

On 30/09/2015 the overall trial end date was changed from 26/11/2011 to 01/12/2016.

Ethics approval

Coventry and Warwickshire REC, November 2009, ref: 09/H1211/87

Study design

Multicentre observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: National Cancer Research Network, Reproductive Health; Subtopic: All Cancers/Misc Sites; Disease: Miscellaneous

Intervention

1. Medical questionnaire, including questions regarding menstrual cycles, past medical history, desire to have children etc.
2. Venepuncture: serum AMH will be measured in patients before commencing chemotherapy and with follow up at 6, 9 months and 1 year compared with an age-matched control group

Study entry: other; patients are recruited at oncology/haematology clinics, or by contacting Midland Fertility Services.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

To assess the impact of different types, doses and duration of chemotherapy on ovarian reserve using AMH, measured at 6, 9, 12 and 60 months

Secondary outcome measures

To assess the accuracy of serum AMH testing in predicting future reproductive capacity, measured at 60 months

Overall trial start date

26/05/2010

Overall trial end date

01/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women aged 18 - 43 years
2. Newly diagnosed cancer - mainly with breast cancer and lymphoma

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned sample size: 100; UK sample size: 100

Participant exclusion criteria

1. A history of previous exposure to gonadotoxic agents and/or radiotherapy
2. Diagnosed with end stage cancer having a very poor prognosis (less than 10% chances of 1 year survival)
3. Significant ovarian pathology or previous bilateral oophrectomy

Recruitment start date

26/05/2010

Recruitment end date

26/11/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Centre House
Walsall
WS9 8LT
United Kingdom

Sponsor information

Organisation

University of Warwick (UK)

Sponsor details

c/o Geraldine Hartshorne
Clinical Sciences Research Institute
Warwick Medical School
Coventry
CV2 2DX
United Kingdom

Sponsor type

University/education

Website

http://www2.warwick.ac.uk/fac/med/research/csri/rh/genesis/

Funders

Funder type

Research organisation

Funder name

Midland Fertility Services Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

01/01/2017

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes