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Completed

NCT Number: NCT04767607

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

The International Peace Maternity and Child Health Hospital

Shanghai, Shanghai Municipality, 200030, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Bilateral oophorectomy or ovarian irradiation before enrollment.
  • Prior chemotherapy.
  • Oral contraceptives before enrollment.
  • Pregnancy or lactation.

Treatment and study plan

Primary outcomes

  1. To evaluate the trend of anti-Müllerian hormone (AMH) level at chemotherapy process and post-chemotherapy in breast cancer patients.

    Time frame: 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 outcomes

  1. To evaluate the trend of Follicle-Stimulating Hormone (FSH) level at chemotherapy process and post-chemotherapy in breast cancer patients.

    Time frame: 1 year.

    Serm FSH concentration will be measured at each chemotherapy process and 1 year post-chemotherapy.

Other outcomes

  1. Number of participants with chemotherapy-induced amenorrhoea/oligomenorrhea and recovery rate of menses during chemotherapy process and 1 year post-chemotherapy treatment.

    Time frame: 1 year.

    Disappearance and reappearance of two consecutive menstrual periods within 21 to 35 days during chemotherapy treatment and 1 year post-chemotherapy.

Sponsors and collaborators

Lead sponsor

International Peace Maternity and Child Health Hospital

Other

Collaborators

  • School of Biomedical Engineering, Shanghai Jiao Tong University

Registry information

Official study title

International Peace Maternity and Child Health Hospital (IPMCH) Affiliated to School of Medicine, Shanghai Jiaotong University, Shanghai, China

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Feb 23, 2021
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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