Breast Cancer, Chemotherapy, Gonadotropin Releasing Hormone Agonists, Ovarian Function, Premenopausal
Conditions
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.
Interventions
Patients received chemotherapy plus a gonadotropin-releasing hormone agonist.
DRUGChemotherapy
Patients received chemotherapy alone.
Sponsors
Helwan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti-mullerian hormone level | Immediately post-procedure (Up to 1 hour) | Anti-mullerian hormone level was calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Egypt
Outcome results
None listed