Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04767607
Status:
COMPLETED
Last Update Posted:
2024-03-06
First Post:
2021-01-26
Brief Title:
Study of Prediction of Ovarian Reserve in Yong Breast Cancer Patients Treated With Chemotherapy
Sponsor:
International Peace Maternity and Child Health Hospital
Organization:
International Peace Maternity and Child Health Hospital
Study Overview
Official Title:
International Peace Maternity and Child Health Hospital IPMCH Affiliated to School of Medicine Shanghai Jiaotong University Shanghai China
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None