BAP-EB as a Predictive Tool for Endometrial Receptivity and Pregnancy Outcome of IVF Treatment
Human Embryonic Stem Cell-derived Trophoblastic Spheroid (BAP-EB) as a Predictive Tool for Endometrial Receptivity and Pregnancy Outcome of in Vitro Fertilization Treatment
1 other identifier
interventional
240
1 country
1
Brief Summary
To determine the predictive value of attachment rate of human embryonic stem cells (hESC)-derived trophoblast spheroids (BAP-EB, embryo surrogate) onto endometrial epithelial cells (EEC) on success of IVF treatment and to use the model to identify EEC surface biomarkers for endometrial receptivity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2016
CompletedFirst Posted
Study publicly available on registry
March 21, 2016
CompletedStudy Start
First participant enrolled
February 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 4, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 13, 2021
CompletedMarch 4, 2022
April 1, 2021
3.4 years
March 9, 2016
March 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cumulative live birth rate
Cumulative birth rate: delivery of a live birth beyond 24 weeks of gestation in that episode of IVF treatment
36 months
Secondary Outcomes (6)
Clinical pregnancy
6 weeks
Ongoing pregnancy
20 weeks
Implantation rate
6 weeks
Miscarriage rate
20 weeks
Multiple pregnancy
6 weeks
- +1 more secondary outcomes
Study Arms (1)
Endometrial biopsy group
EXPERIMENTALWomen who have an endometrial biopsy 2-3 months prior to IVF
Interventions
An endometrial biopsy taken 2-3 months prior to IVF cycle
Eligibility Criteria
You may qualify if:
- Subfertile women indicated for the first IVF or women with cryopreserved embryos at HKU-QMH CARE, HKU-SZH CARE and SCCARC
- Women indicated for IVF treatment with a normal uterine cavity as demonstrated by saline infusion sonogram or hysteroscopy
- Women with regular ovulatory cycles
You may not qualify if:
- The presence of an endometrial polyp or fibroid distorting the uterine cavity
- The presence of untreated hydrosalpinx
- IVF treatment carried out for preimplantation genetic diagnosis
- The use of donor oocytes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The University of Hong Konglead
- The University of Hong Kong-Shenzhen Hospitalcollaborator
- Kwong Wah Hospitalcollaborator
Study Sites (1)
Department of Obstetrics and Gynaecology
Hong Kong, Hong Kong, China
Related Publications (1)
Lee YL, Ruan H, Lee KC, Fong SW, Yue C, Chen ACH, Lee KF, Lam MT, Yeung WSB, Li RHW, Ng EHY. Attachment of a trophoblastic spheroid onto endometrial epithelial cells predicts cumulative live birth in women aged 35 and older. Fertil Steril. 2023 Aug;120(2):268-276. doi: 10.1016/j.fertnstert.2023.03.013. Epub 2023 Mar 20.
PMID: 36940739DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ernest HY Ng
The University of Hong Kong
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2016
First Posted
March 21, 2016
Study Start
February 1, 2017
Primary Completion
July 4, 2020
Study Completion
September 13, 2021
Last Updated
March 4, 2022
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share