Oocyte Recovery During Tamoxifen Adjuvant Therapy

NCT02355600 | Unknown

• 1 other identifier: 2014/0642
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Oocyte; Tamoxifen; Fertility preservation

Outcome Measures

Primary Outcomes (1)

• Metaphase II oocytes retrieved

  24 months

Secondary Outcomes (3)

• Number of frozen embryos

  24 months

• Morphologic score of frozen embryos

  24 months

• Pregnancy rate

  Expected average of 6 years

Interventions

Oocyte retrieval OTHER

Tamoxifen given at a fixed dose for invasive breast cancer adjuvant hormonotherapy or for breast cancer prophylaxis.

Also known as: Oocyte pick-up

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto de Investigacion Sanitaria La Fe: lead

Study Sites (1)

Hospital Universitari i Politècnic La Fe

Valencia, Valencia, 46026, Spain

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Oocyte Retrieval

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Tissue and Organ Harvesting; Transplantation; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• César Diaz-Garcia, MD

  IIS La Fe

  PRINCIPAL INVESTIGATOR

Central Study Contacts

César Diaz-Garcia, MD

CONTACT

cesar.diaz@uv.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2015
• First Posted: February 4, 2015
• Study Start: November 1, 2014
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: September 22, 2016

Record last verified: 2016-09

Locations

ES (1)