Clinical trial NCT04767607: Study of Prediction of Ovarian Reserve in Yong Breast Cancer Patients Treated With Chemotherapy
Official title: International Peace Maternity and Child Health Hospital (IPMCH) Affiliated to School of Medicine, Shanghai Jiaotong University, Shanghai, China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast Cancer
Chemotherapy
ovarian reserve
Lead sponsor: International Peace Maternity and Child Health Hospital
Sponsor class: OTHER
Collaborators: name: School of Biomedical Engineering, Shanghai Jiao Tong University
First posted: 2021-02-23
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate the trend of anti-Müllerian hormone (AMH) level at chemotherapy process and post-chemotherapy in breast cancer patients.
timeFrame: 1 year.
Secondary outcomes:
measure: To evaluate the trend of Follicle-Stimulating Hormone (FSH) level at chemotherapy process and post-chemotherapy in breast cancer patients.
timeFrame: 1 year.
Other outcomes:
measure: Number of participants with chemotherapy-induced amenorrhoea/oligomenorrhea and recovery rate of menses during chemotherapy process and 1 year post-chemotherapy treatment.
timeFrame: 1 year.
Locations:
city: Shanghai
country: China
facility: The International Peace Maternity and Child Health Hospital
state: Shanghai
Study officials:
affiliation: The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University
name: Dongmei Lai, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.