BAP-EB as a Predictive Tool for Endometrial Receptivity and Pregnancy Outcome of IVF Treatment
Primary Purpose
Subfertility
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
endometrial biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Subfertility focused on measuring Subfertility, In-vitro fertilization, BAP-EB, Endometrial epithelial cells, Repeated implantation failure
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Department of Obstetrics and Gynaecology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Endometrial biopsy group
Arm Description
Women who have an endometrial biopsy 2-3 months prior to IVF
Outcomes
Primary Outcome Measures
Cumulative live birth rate
Cumulative birth rate: delivery of a live birth beyond 24 weeks of gestation in that episode of IVF treatment
Secondary Outcome Measures
Clinical pregnancy
presence of at least one gestational sac on ultrasound at 6 weeks
Ongoing pregnancy
presence of at least one fetal heart pulsation on ultrasound beyond 20 weeks
Implantation rate
Number of ultrasound detected embryonic sacs divided by the number of embryos transferred.
Miscarriage rate
Number of miscarriages before 20 weeks divided by the number of women with a positive pregnancy test.
Multiple pregnancy
A pregnancy with more than one gestational sac detected on ultrasound at 6 weeks
Live birth rate
Live birth rate: delivery of a live birth beyond 24 weeks of gestation
Full Information
NCT ID
NCT02713854
First Posted
March 9, 2016
Last Updated
March 2, 2022
Sponsor
The University of Hong Kong
Collaborators
The University of Hong Kong-Shenzhen Hospital, Kwong Wah Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02713854
Brief Title
BAP-EB as a Predictive Tool for Endometrial Receptivity and Pregnancy Outcome of IVF Treatment
Official Title
Human Embryonic Stem Cell-derived Trophoblastic Spheroid (BAP-EB) as a Predictive Tool for Endometrial Receptivity and Pregnancy Outcome of in Vitro Fertilization Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
July 4, 2020 (Actual)
Study Completion Date
September 13, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Hong Kong
Collaborators
The University of Hong Kong-Shenzhen Hospital, Kwong Wah Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Study Objectives and Purpose:
There are three objectives in this study:
To determine the predictive value of the attachment rate of BAP-EB onto EEC on success of IVF treatment. The attachment rate of BAP-EB onto EEC of subfertile women in a natural cycle preceding the IVF cycle will be determined and correlated with the cumulative live birth rate in a subsequent stimulated IVF cycle and the derived frozen-thawed embryo transfer (FET) cycles.
To identify the surface molecules on EEC responsible for attaching to BAP-EB. The biotin-labeled primary EEC surface proteins that bind onto BAP-EB will be purified and identified by mass spectrometry. The bound proteins from "receptive" and "non-receptive" endometrial cell lines will be compared. The expression of the surface proteins on endometrial samples obtained in Objective 1will be correlated with their BAP-EB attachment rate.
To compare the BAP-EB attachment rate and expression of the attachment-related "receptive" EEC surface molecules between pre-receptive and receptive endometrium and between women with repeated implantation failure (RIF) and subfertile women due to male factors. To identify women with endometrial defects, women with RIF and failed IVF after preimplantation genetic screening (PGS) will be recruited. The latter recruitment criterion excludes RIF due to embryo aneuploidy.
Subjects:
Patients will be recruited from the Centre of Assisted Reproduction and Embryology, the University of Hong Kong at Queen Mary Hospital (HKU-QMH CARE) and at University of Hong Kong-Shenzhen Hospital (HKU-SZH CARE), the Dr Stephen Chow Chun-kay Assisted Reproduction Centre, Kwong Wah Hospital (SCCARC).
Treatment of Subjects:
Endometrial biopsies will be collected from the subjects and the attachment rate of BAP-EB onto isolated EEC will be associated with the implantation and pregnancy outcomes in IVF and the expressions of the isolated surface proteins.
Study duration: 36 months
Assessment of Safety:
Specification of safety parameters. Abdominal pain after endometrial aspirate
The methods and timing for assessing, recording, and analysing safety parameters. Subjects will be asked to contact investigators if they notice abdominal pain after endometrial aspirate
Procedures for eliciting reports of and for recording and reporting adverse event and intercurrent illnesses. Any abdominal pain will be documented in subjects' medical notes and they will be asked for any adverse effects and intercurrent illness when receiving IVF treatment.
The type and duration of the follow-up of subjects after adverse events. Subjects will be followed up in the Department of Obstetrics and Gynaecology as long as they have the adverse events.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subfertility
Keywords
Subfertility, In-vitro fertilization, BAP-EB, Endometrial epithelial cells, Repeated implantation failure
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Endometrial biopsy group
Arm Type
Experimental
Arm Description
Women who have an endometrial biopsy 2-3 months prior to IVF
Intervention Type
Procedure
Intervention Name(s)
endometrial biopsy
Intervention Description
An endometrial biopsy taken 2-3 months prior to IVF cycle
Primary Outcome Measure Information:
Title
Cumulative live birth rate
Description
Cumulative birth rate: delivery of a live birth beyond 24 weeks of gestation in that episode of IVF treatment
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Clinical pregnancy
Description
presence of at least one gestational sac on ultrasound at 6 weeks
Time Frame
6 weeks
Title
Ongoing pregnancy
Description
presence of at least one fetal heart pulsation on ultrasound beyond 20 weeks
Time Frame
20 weeks
Title
Implantation rate
Description
Number of ultrasound detected embryonic sacs divided by the number of embryos transferred.
Time Frame
6 weeks
Title
Miscarriage rate
Description
Number of miscarriages before 20 weeks divided by the number of women with a positive pregnancy test.
Time Frame
20 weeks
Title
Multiple pregnancy
Description
A pregnancy with more than one gestational sac detected on ultrasound at 6 weeks
Time Frame
6 weeks
Title
Live birth rate
Description
Live birth rate: delivery of a live birth beyond 24 weeks of gestation
Time Frame
42 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ernest HY Ng
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Obstetrics and Gynaecology
City
Hong Kong
State/Province
Hong Kong
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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BAP-EB as a Predictive Tool for Endometrial Receptivity and Pregnancy Outcome of IVF Treatment
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