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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04767607
• Other study ID #: GFY202001
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: July 1, 2023

Study information

• Verified date: March 2024
• Source: International Peace Maternity and Child Health Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
China	The International Peace Maternity and Child Health Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
International Peace Maternity and Child Health Hospital	School of Biomedical Engineering, Shanghai Jiao Tong University

Country where clinical trial is conducted

China, 

References & Publications (3)

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-Mullerian 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. — View Citation

Freour T, Barriere P, Masson D. Anti-mullerian 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. — View Citation

Lie Fong S, Lugtenburg PJ, Schipper I, Themmen AP, de Jong FH, Sonneveld P, Laven JS. Anti-mullerian 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with chemotherapy-induced amenorrhoea/oligomenorrhea and recovery rate of menses during chemotherapy process and 1 year post-chemotherapy treatment.	Disappearance and reappearance of two consecutive menstrual periods within 21 to 35 days during chemotherapy treatment and 1 year post-chemotherapy.	1 year.
Primary	To evaluate the trend of anti-Müllerian hormone (AMH) level at chemotherapy process and post-chemotherapy in breast cancer patients.	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	To evaluate the trend of Follicle-Stimulating Hormone (FSH) level at chemotherapy process and post-chemotherapy in breast cancer patients.	Serm FSH concentration will be measured at each chemotherapy process and 1 year post-chemotherapy.	1 year.