SubfertilityNCT02713854
BAP-EB as a Predictive Tool for Endometrial Receptivity and Pregnancy Outcome of IVF Treatment
A study testing endometrial biopsy in people with Subfertility, run by The University of Hong Kong at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Subfertility
- What is being tested?
- endometrial biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2017to 13 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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:
- 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.
- Conditions
- Subfertility
- Being tested
- endometrial biopsy
- Keywords
- Subfertility, In-vitro fertilization, BAP-EB, Endometrial epithelial cells, Repeated implantation failure
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endometrial biopsyProcedure or surgery
An endometrial biopsy taken 2-3 months prior to IVF cycle
| Study group | Role | What they receive |
|---|---|---|
| Endometrial biopsy group | Experimental | Women who have an endometrial biopsy 2-3 months prior to IVF Receives: Procedure: endometrial biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative live birth rate
Cumulative birth rate: delivery of a live birth beyond 24 weeks of gestation in that episode of IVF treatment
Measured: 36 months
Secondary outcomes (6)
Clinical pregnancy
presence of at least one gestational sac on ultrasound at 6 weeks
Measured: 6 weeks
Ongoing pregnancy
presence of at least one fetal heart pulsation on ultrasound beyond 20 weeks
Measured: 20 weeks
Implantation rate
Number of ultrasound detected embryonic sacs divided by the number of embryos transferred.
Measured: 6 weeks
Miscarriage rate
Number of miscarriages before 20 weeks divided by the number of women with a positive pregnancy test.
Measured: 20 weeks
Multiple pregnancy
A pregnancy with more than one gestational sac detected on ultrasound at 6 weeks
Measured: 6 weeks
Live birth rate
Live birth rate: delivery of a live birth beyond 24 weeks of gestation
Measured: 42 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study start1 Feb 2017
- Primary completion4 Jul 2020
- Study completion13 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SubfertilityStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Hong Kong-Shenzhen Hospital, Kwong Wah Hospital
- Responsible party
- Sponsor
- Investigators
- Ernest HY Ng, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02713854
- Sponsor's protocol ID
- BAP-EB-2016-protocol-v1
- Status last verified
- Apr 2021
- First submitted
- 9 Mar 2016
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02713854
- Acronym / sponsor ID
- BAP-EB-2016-protocol-v1
- Conditions
- Subfertility
- Keywords
- Subfertility, In-vitro fertilization, BAP-EB, Endometrial epithelial cells, Repeated implantation failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- The University of Hong Kong-Shenzhen Hospital, Kwong Wah Hospital
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 4 Jul 2020 (actual)
- Study completion
- 13 Sep 2021 (actual)
- First posted
- 21 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endometrial biopsy group | Experimental | Procedure: endometrial biopsyWomen who have an endometrial biopsy 2-3 months prior to IVF |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endometrial biopsyAn endometrial biopsy taken 2-3 months prior to IVF cycle | Procedure or surgery | Endometrial biopsy group |
Primary outcome
Cumulative live birth rate
Time frame: 36 months
Cumulative birth rate: delivery of a live birth beyond 24 weeks of gestation in that episode of IVF treatment
6 secondary outcomes
Clinical pregnancy
Time frame: 6 weeks
Ongoing pregnancy
Time frame: 20 weeks
Implantation rate
Time frame: 6 weeks
Miscarriage rate
Time frame: 20 weeks
Multiple pregnancy
Time frame: 6 weeks
Live birth rate
Time frame: 42 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Derived from this study: PubMed 36940739Lee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ernest HY Ng principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endometrial biopsy in people with Subfertility, run by The University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative live birth rate (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02713854, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2022.