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

NCT ID: NCT07127315

Last Updated: 2025-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-01

Study Completion Date

2024-07-01

Brief Summary

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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

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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.

Conditions

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Gonadotropin Releasing Hormone Agonists Ovarian Function Premenopausal Breast Cancer Chemotherapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Intervention group

Patients received chemotherapy plus a gonadotropin-releasing hormone agonist.

Gonadotropin-releasing hormone agonist

Intervention Type DRUG

Patients received chemotherapy plus a gonadotropin-releasing hormone agonist.

Control group

Patients received chemotherapy alone.

Chemotherapy

Intervention Type DRUG

Patients received chemotherapy alone.

Interventions

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Gonadotropin-releasing hormone agonist

Patients received chemotherapy plus a gonadotropin-releasing hormone agonist.

Intervention Type DRUG

Chemotherapy

Patients received chemotherapy alone.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Helwan University

OTHER

Sponsor Role lead

Responsible Party

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Fatma Mohsen Kamal

Assistant Lecturer of Clinical Oncology, Faculty of Medicine, Helwan University, Helwan, Egypt.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Helwan University

Helwan, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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51-2022

Identifier Type: -

Identifier Source: org_study_id

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