Oocyte Recovery During Tamoxifen Adjuvant Therapy (TAMOXIFERT)

September 21, 2016 updated by: Instituto de Investigacion Sanitaria La Fe

Tamoxifen as Adjuvant Treatment in Breast Cancer and Its Impact on Ovarian Function

Survival in young patients with cancer has increased and also have increased the adverse long-term side effects of chemotherapy, there is a large number of women who experience loss of ovarian function without accomplishing their reproductive desire due to gonadotoxic treatment. The ovarian reserve determine the response to controlled ovarian hyperstimulation in fertility preservation treatments as well as in assisted reproduction techniques. Improving this reserve by avoiding its depletion during the process could result in increase fertility rates after cancer treatment.

Collecting follicles during tamoxifen treatment would increase the number of cryopreserved oocytes and thus rise the potential ovarian reserve in these patients, which is reduced due to age, chemotherapy and length of treatments.

The aim of this study is to retrieve viable mature oocytes during adjuvancy with tamoxifen in breast cancer patients to improve the probability of subsequent pregnancy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

New chemotherapy regimens and management options developed during the last 20 years have yielded increased survival rates in cancer patients but they also cause side effects such as premature ovarian failure and infertility due to their gonadotoxicity. Hormone therapy also increases survival rates in breast cancer patients; tamoxifen, a selective estrogen receptor modulator, has been proven to reduce the risk of recurrence and mortality due to breast cancer when administered during 10 years.

The risk of premature ovarian failure depends not only on the gonadotoxicity of chemotherapy but also on the age of the patient, therefore although tamoxifen is not gonadotoxic itself, it can compromise fertility because of the long length of treatment and the subsequent delay in childbearing.

On the other hand, tamoxifen is a drug that can be used in assisted reproduction techniques to induce ovarian stimulation, therefore, the tamoxifen treatment followed by breast cancer patients represent somehow a way of continuous ovarian stimulation. If viable oocytes could be retrieved during the long-term hormonal treatment with tamoxifen, there will be an option to use them to restore fertility afterwards.

STUDY DESIGN:

Patients included in the study who have normal menstrual periods will be monitored by sonography (antral follicle count) and serum hormonal levels: E2 (oestradiol), P4 (progesterone), FSH (follicle stimulating hormone) and LH (luteinizing hormone) from the second day of their cycle. Patients without spontaneous menstruations will perform periodic visits every 15 days until images corresponding with antral follicle definition will be seen, this will be considered day 2 of the cycle.

Follow-up of the antral follicles will be done with sonography and serum hormonal levels according to the protocols of the investigators in vitro fertilization unit. When a follicle of more than 18 mm is seen, 250 µg of hCG (human chorionic gonadotropin) will be administered and 36 hours after, transvaginal oocyte retrieval will be performed. Oocyte and embryo quality assessment will be performed according to morphological ASEBIR (association for the study of reproduction biology) classification on day +2 and +3. Grade 1 and 2 embryos on day +3 will be cryopreserved.

Patients requiring assisted reproduction technologies to get pregnant after completion of their oncologic treatment will have their embryos thawed and subsequently transferred.

FOLLOW-UP:

During the time oocytes retrieved are being used or until the end of gestation in case the patient become pregnant.

Bearing in mind that most of the patients in our center undergo 5 year of tamoxifen treatment, it will be assumed a maximum follow-up of 6 years.

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitari I Politecnic La Fe
        • Contact:
        • Sub-Investigator:
          • Ainhoa Romero Espinós, MD
        • Sub-Investigator:
          • Alicia Marzal Escrivá, MD
        • Sub-Investigator:
          • Antonio Pellicer, MD
        • Sub-Investigator:
          • Natalia Fischer, MD
        • Sub-Investigator:
          • Daniella Galliano, MD
        • Sub-Investigator:
          • Ignacio Iniesta, BSc
        • Sub-Investigator:
          • Irene Peinado, BSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 33 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Young breast cancer patients (with positive estrogen receptors) using tamoxifen as adjuvant treatment

Description

Inclusion Criteria:

  • Breast cancer patients whose tumors have positive hormone receptors (ER+) subsidiary of adjuvant treatment with tamoxifen
  • Reproductive desire

Exclusion Criteria:

  • Having received chemotherapy agents less than 12 months ago
  • Current treatment with GnRH analogues
  • Age > 35 years old
  • Contraindication for follicular punction or hCG administration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Metaphase II oocytes retrieved
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of frozen embryos
Time Frame: 24 months
24 months
Morphologic score of frozen embryos
Time Frame: 24 months
24 months
Pregnancy rate
Time Frame: Expected average of 6 years
pregnancy rates after the use of frozen embryos generated during tamoxifen treatment
Expected average of 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Investigacion Sanitaria La Fe

Investigators

  • Principal Investigator: César Diaz-Garcia, MD, Iis la Fe

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

January 22, 2015

First Submitted That Met QC Criteria

February 3, 2015

First Posted (Estimate)

February 4, 2015

Study Record Updates

Last Update Posted (Estimate)

September 22, 2016

Last Update Submitted That Met QC Criteria

September 21, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/0642

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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