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CompletedNCT02713854Updated Mar 4, 2022

BAP-EB as a Predictive Tool for Endometrial Receptivity and Pregnancy Outcome of IVF Treatment

An interventional study of endometrial biopsy in Subfertility, sponsored by The University of Hong Kong. Completed at 1 site in China. Open to female participants aged 18 Years to 42 Years. Per ClinicalTrials.gov, last updated 2022-03-04.

Sponsored by The University of Hong Kong · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
240
Allocation
Not applicable
Ages
18 Years to 42 Years
Sex
Female
01

Study 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.

Read the detailed description

Study Objectives and Purpose:

There are three objectives in this study:

  1. 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.
  2. 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.
  3. 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:

  1. Specification of safety parameters. Abdominal pain after endometrial aspirate
  2. 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
  3. 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.
  4. 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.
02

Conditions studied

  • Subfertility

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Keywords

  • Subfertility
  • In-vitro fertilization
  • BAP-EB
  • Endometrial epithelial cells
  • Repeated implantation failure
03

In context

Infertility

2,541 studies on the registry are indexed under Infertility; 405 are open to participants now.

This study's enrollment of 240 is above the median of 120 across 1,722 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

The University of Hong Kong is the lead sponsor of 1,286 studies on the registry; 343 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse The University of Hong Kong studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 42 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
240 participants (actual)

Study arms

  • Experimental
    Endometrial biopsy group

    Women who have an endometrial biopsy 2-3 months prior to IVF

    Procedure: endometrial biopsy

Interventions

  • Procedureendometrial biopsy

    An endometrial biopsy taken 2-3 months prior to IVF cycle

06

What researchers measure

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

    Time frame: 36 months

Secondary outcomes

  1. Clinical pregnancy

    presence of at least one gestational sac on ultrasound at 6 weeks

    Time frame: 6 weeks

  2. Ongoing pregnancy

    presence of at least one fetal heart pulsation on ultrasound beyond 20 weeks

    Time frame: 20 weeks

  3. Implantation rate

    Number of ultrasound detected embryonic sacs divided by the number of embryos transferred.

    Time frame: 6 weeks

  4. Miscarriage rate

    Number of miscarriages before 20 weeks divided by the number of women with a positive pregnancy test.

    Time frame: 20 weeks

  5. Multiple pregnancy

    A pregnancy with more than one gestational sac detected on ultrasound at 6 weeks

    Time frame: 6 weeks

  6. Live birth rate

    Live birth rate: delivery of a live birth beyond 24 weeks of gestation

    Time frame: 42 weeks

07

Study locations

1 site
  • Department of Obstetrics and Gynaecology
    Hong Kong, Hong Kong, China
08

References and documents

Publications

  • 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. PubMed 36940739 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2017 to primary completion in Jul 2020, 41 months.

Of 498 non-industry interventional studies with no phase under Infertility, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 41 months is above that.

Counting every sponsor, half of 541 studies reached it within 23 months; a quarter within 10 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 9, 2016
First posted
Mar 21, 2016
StartActual
Feb 1, 2017
Primary completionActual
Jul 4, 2020
CompletionActual
Sep 13, 2021
Last update
Mar 4, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02713854
Lead sponsor
The University of Hong Kong
Collaborators
The University of Hong Kong-Shenzhen Hospital, Kwong Wah Hospital
Responsible party
Sponsor
First posted
Mar 21, 2016
Start date
Feb 1, 2017
Primary completion
Jul 4, 2020
Completion
Sep 13, 2021
Last update
Mar 4, 2022

Study contacts

Ernest HY Ng
principal investigator · The University of Hong Kong

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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