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

NCT07127315 | Completed

• 1 other identifier: 51-2022
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gonadotropin Releasing Hormone Agonists; Ovarian Function; Premenopausal; Breast Cancer; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Anti-mullerian hormone level

  Anti-mullerian hormone level was calculated.

  Immediately post-procedure (Up to 1 hour)

Secondary Outcomes (4)

• Follicle-stimulating hormone level

  Immediately post-procedure (Up to 1 hour)

• Estradiol level

  Immediately post-procedure (Up to 1 hour)

• Disease-free survival

  2 years post-procedure

• Overall survival

  2 years post-procedure

Study Arms (2)

Intervention group

Patients received chemotherapy plus a gonadotropin-releasing hormone agonist.

Drug: Gonadotropin-releasing hormone agonist

Control group

Patients received chemotherapy alone.

Drug: Chemotherapy

Interventions

Gonadotropin-releasing hormone agonist DRUG

Patients received chemotherapy plus a gonadotropin-releasing hormone agonist.

Intervention group

Chemotherapy DRUG

Patients received chemotherapy alone.

Control group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Premenopausal female patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

100 females with early-stage breast cancer were recruited from the Clinical Oncology Department at Helwan University Hospital for this interventional prospective cross-sectional case-control cohort study.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Helwan University: lead

Study Sites (1)

Helwan University

Helwan, 11795, Egypt

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Gonadotropin-Releasing Hormone; Drug Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Clinical Oncology, Faculty of Medicine, Helwan University, Helwan, Egypt.

Study Record Dates

• First Submitted: August 10, 2025
• First Posted: August 17, 2025
• Study Start: July 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: July 1, 2024
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)