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

March 5, 2024 updated by: Dongmei Lai, International Peace Maternity and Child Health Hospital

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • The International Peace Maternity and Child Health Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

200 premenopausal breast cancer female patients of age 18-50 treated in the International Peace Maternity and Child Health Hospital

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Breast cancer plus chemotherapy
Patients of the group will receive chemotherapy treatment.
Breast cancer without chemotherapy
Patients of the group will not receive chemotherapy treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Peace Maternity and Child Health Hospital

Collaborators

School of Biomedical Engineering, Shanghai Jiao Tong University

Investigators

  • Principal Investigator: Dongmei Lai, M.D., The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Actual)

July 1, 2022

Study Completion (Actual)

July 1, 2023

Study Registration Dates

First Submitted

January 26, 2021

First Submitted That Met QC Criteria

February 22, 2021

First Posted (Actual)

February 23, 2021

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GFY202001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The public can require the data and protocol from clinicaltrials.gov posted by investigator.

IPD Sharing Time Frame

2 years

IPD Sharing Access Criteria

Public

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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