Study of Prediction of Ovarian Reserve in Yong Breast Cancer Patients Treated With Chemotherapy

International Peace Maternity and Child Health Hospital

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT04767607

GFY202001

Details and patient eligibility

About

The purpose of this study is to predict the ovarian reserve, especially premature ovarian insufficient (POI), in young breast cancer patients during chemotherapy treatment using ultrasensitive anti-Müllerian hormone (AMH) detection method.

Full description

Young breast cancer women are often treated with adjuvant chemotherapy and neoadjuvant chemotherapy regiments include cyclophosphamide, anthracyclines and a taxane. These treatments can adversely affect ovarian function across the lifespan, causing premature menopause, infertility, and POI. AMH is currently the most robust marker of prediction of ovarian injury in cancer patients during chemotherapy in compare with other sexual hormone marker (such as follicle stimulating hormone (FSH), inhibin B) and ovarian volume, and is a more convenient way of prediction of ovarian reserve compare antral follicle count (AFC). But most of the patients' AMH levels become undetectable (using common AMH kits) after several cycle of chemotherapy, and some of these patients' AMH levels will maintained at a low level after chemotherapy, while others will recover. Using the ultrasensitive AMH detection method is expected to accurately assess the ovarian reserve during the chemotherapy treatment, predicting the risk of ovarian failure, and providing patients with ovarian and fertility function protection recommendations, such as using GnRHa regents during treatment and providing assisted reproductive technology consultants.

Enrollment: 300 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Female 18-50 years.
2. Suffering from breast cancer.
3. Treated with adjuvant or neoadjuvant chemotherapy.
4. Having regular menstrual cycle before chemotherapy.

Exclusion criteria

1. Bilateral oophorectomy or ovarian irradiation before enrollment.
2. Prior chemotherapy.
3. Oral contraceptives before enrollment.
4. Pregnancy or lactation.

Trial design

300 participants in 2 patient groups

Breast cancer plus chemotherapy

Description:

Patients of the group will receive chemotherapy treatment.

Breast cancer without chemotherapy

Description:

Patients of the group will not receive chemotherapy treatment.