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Assessing Gonadotropin-Releasing Hormone Agonists Benefit in Preserving the Ovarian Function in Premenopausal Breast Cancer Patients During Chemotherapy

H

Helwan University

Status

Completed

Conditions

Gonadotropin Releasing Hormone Agonists
Breast Cancer
Chemotherapy
Premenopausal
Ovarian Function

Treatments

Drug: Chemotherapy
Drug: Gonadotropin-releasing hormone agonist

Study type

Observational

Funder types

Other

Identifiers

NCT07127315
51-2022

Details and patient eligibility

About

The purpose of this study is to investigate the benefits of gonadotropin-releasing hormone agonist administration during chemotherapy on preserving ovarian function and Fertility in Premenopausal breast cancer patients, as assessed by anti-mullerian hormone levels, luteinizing hormone (LH), follicle-stimulating hormone (FSH), and estradiol (E2) levels.

Full description

The annually estimated number of females diagnosed with cancer is about 6.6 million, 10% of whom are premenopausal.

To minimize the risk of ovarian dysfunction and infertility for these patients, ovarian reserve differs widely from one female to another, but it could be assessed by Ultrasound to reveal antral follicle count (AFC). Also, the hormonal levels of anti-Müllerian hormone (AMH), estradiol (E2), and follicle-stimulating hormone FSH are valuable indicators for fertility.

Enrollment

100 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Premenopausal female patients 18-45 years.
  • Female patients with pathologically confirmed breast cancer and receiving a chemotherapy regimen, either adjuvant or neoadjuvant, containing a gonadotoxic agent.
  • Female patients with performance status (PS) ≤ 2.

Exclusion criteria

  • All female Patients with metastatic cancer.
  • Patients underwent total abdominal hysterectomy and bilateral salpingo-oophorectomy, or patients received radiotherapy on the pelvis.
  • Patient with end-organ failure.
  • Patients with performance status >2.
  • Male with breast cancer.
  • Post-menopausal females.

Trial design

100 participants in 2 patient groups

Intervention group
Description:
Patients received chemotherapy plus a gonadotropin-releasing hormone agonist.
Treatment:
Drug: Gonadotropin-releasing hormone agonist
Control group
Description:
Patients received chemotherapy alone.
Treatment:
Drug: Chemotherapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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