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

Overview

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 1, 2022

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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • International Peace Maternity and Child Health Hospital
  • Collaborator
    • School of Biomedical Engineering, Shanghai Jiao Tong University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dongmei Lai, Principal Investigator – International Peace Maternity and Child Health Hospital
  • Overall Official(s)
    • Dongmei Lai, M.D., Principal Investigator, The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University
  • Overall Contact(s)
    • Dongmei Lai, M.D., 86-021-64070434, laidongmei@hotmail.com

References

Dezellus A, Barriere P, Campone M, Lemanski C, Vanlemmens L, Mignot L, Delozier T, Levy C, Bendavid C, Debled M, Bachelot T, Jouannaud C, Loustalot C, Mouret-Reynier MA, Gallais-Umbert A, Masson D, Freour T. Prospective evaluation of serum anti-Müllerian hormone dynamics in 250 women of reproductive age treated with chemotherapy for breast cancer. Eur J Cancer. 2017 Jul;79:72-80. doi: 10.1016/j.ejca.2017.03.035. Epub 2017 Apr 29.

Fréour T, Barrière P, Masson D. Anti-müllerian hormone levels and evolution in women of reproductive age with breast cancer treated with chemotherapy. Eur J Cancer. 2017 Mar;74:1-8. doi: 10.1016/j.ejca.2016.12.008. Epub 2017 Jan 28. Review.

Lie Fong S, Lugtenburg PJ, Schipper I, Themmen AP, de Jong FH, Sonneveld P, Laven JS. Anti-müllerian hormone as a marker of ovarian function in women after chemotherapy and radiotherapy for haematological malignancies. Hum Reprod. 2008 Mar;23(3):674-8. doi: 10.1093/humrep/dem392. Epub 2008 Jan 23.

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