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

Completed

• Conditions: Gonadotropin Releasing Hormone Agonists; Ovarian Function; Premenopausal; Breast Cancer; Chemotherapy
• Interventions: Drug: Gonadotropin-releasing hormone agonist; Drug: Chemotherapy

• Registration Number: NCT07127315
• Lead Sponsor: Helwan University

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.

Detailed 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.

Study Timeline

• Study Start: 2022-07-01
• Primary Completion: 2024-06-01
• Study Completion: 2024-07-01
• Status Verified: 2025-08
• Study First Submitted: 2025-08-10
• Study First Submitted QC: 2025-08-10
• Last Update Submitted: 2025-08-10
• Study First Posted: 2025-08-17
• Last Update Posted: 2025-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Anti-mullerian hormone level	Immediately post-procedure (Up to 1 hour)	Anti-mullerian hormone level was calculated.

Secondary Outcome Measures

Name	Time	Method
Follicle-stimulating hormone level	Immediately post-procedure (Up to 1 hour)	Follicle-stimulating hormone level was calculated.
Estradiol level	Immediately post-procedure (Up to 1 hour)	Estradiol (E2) level was calculated.
Disease-free survival	2 years post-procedure	Disease-free survival (DFS) was calculated.
Overall survival	2 years post-procedure	Overall survival (OS) was calculated.

Trial Locations

Locations (1)

Helwan University; 🇪🇬 Helwan, Egypt