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

Completed

• Conditions: Breast Cancer

• Registration Number: NCT04767607
• Lead Sponsor: International Peace Maternity and Child Health Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2020-06-01
• Study First Submitted: 2021-01-26
• Study First Submitted QC: 2021-02-22
• Study First Posted: 2021-02-23
• Primary Completion: 2022-07-01
• Study Completion: 2023-07-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the trend of anti-Müllerian hormone (AMH) level at chemotherapy process and post-chemotherapy in breast cancer patients.	1 year.	Serum anti-Müllerian hormone (AMH) concentration can be measured on any day during the menstrual cycle. Serum AMH will be measured at each chemotherapy administration and 1 year post-chemotherapy.

Secondary Outcome Measures

Name	Time	Method
To evaluate the trend of Follicle-Stimulating Hormone (FSH) level at chemotherapy process and post-chemotherapy in breast cancer patients.	1 year.	Serm FSH concentration will be measured at each chemotherapy process and 1 year post-chemotherapy.

Trial Locations

Locations (1)

The International Peace Maternity and Child Health Hospital; 🇨🇳 Shanghai, Shanghai, China