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NCT Number: NCT07127315

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

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.

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Key information

Conditions

Gonadotropin Releasing Hormone Agonists Breast Cancer Breast Diseases Breast Neoplasms Chemotherapy Neoplasms Neoplasms by Site Ovarian Function Premenopausal Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Helwan University

Helwan, 11795, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gonadotropin-releasing hormone agonist

Drug

Patients received chemotherapy plus a gonadotropin-releasing hormone agonist.

Chemotherapy

Drug

Patients received chemotherapy alone.

Primary outcomes

  1. Anti-mullerian hormone level

    Time frame: Immediately post-procedure (Up to 1 hour)

    Anti-mullerian hormone level was calculated.

Secondary outcomes

  1. Follicle-stimulating hormone level

    Time frame: Immediately post-procedure (Up to 1 hour)

    Follicle-stimulating hormone level was calculated.

  2. Estradiol level

    Time frame: Immediately post-procedure (Up to 1 hour)

    Estradiol (E2) level was calculated.

  3. Disease-free survival

    Time frame: 2 years post-procedure

    Disease-free survival (DFS) was calculated.

  4. Overall survival

    Time frame: 2 years post-procedure

    Overall survival (OS) was calculated.

Sponsors and collaborators

Lead sponsor

Helwan University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 17, 2025
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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