InfertilityNCT03689101
The Relationship Between CD138 Count of Endometrium and Reproductive Outcome
A study testing Endometrial biopsies in people with Infertility, run by Reproductive & Genetic Hospital of CITIC-Xiangya at 1 site in China.
Trial summary
It's well known, endometritis affects reproductive outcomes. Though CD138 counting as one new diagnosis measure for endometritis, diagnostic criterion of this measure isn't consistent. And if the CD138 counting is correlation to the outcome of reproductive is not clear. Read more about this study
- Who is it for?
- Ages 20 to 38 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Endometrial biopsies
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteChina
- Study dates
- 21 Mar 2016to 2 Feb 2019
- 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 20 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- age between20 and 38 years;
- regular menstrual cycles;
- body mass index (BMI) ranged from 18 to 25
Who cannot join
- uterine abnormalities;
- intrauterine adhesions（moderate - severe）, advanced endometriosis, adenomyosis, untreated hydrosalpinx, uterine fibroids (submucosal fibroids, nonmucosal fibroids >4.0 cm and/or endometrial pressure)
Trial locations and contacts
1 site in 1 country.
China1 site
Reproductive & Genetic Hospital of CITIC-XIANGYA
Changsha, Hunan, 410000
About this study
Official title: To Explore the Relationship Between Endometrial CD138 Count and Pregnancy Outcome Following Frozen Embryo Transfer in Natural Cycles
It's well known, endometritis affects reproductive outcomes. Though CD138 counting as one new diagnosis measure for endometritis, diagnostic criterion of this measure isn't consistent. And if the CD138 counting is correlation to the outcome of reproductive is not clear.
Firstly, This study aims to explore the relationship between endometrial CD138 count and pregnancy outcome following frozen embryo transfer in natural cycles. Secondly , the investigators want to find a cut-off value which is related to reproduction outcome.
- Conditions
- Infertility
- Being tested
- Endometrial biopsies
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrial biopsiesProcedure or surgery
Endometrial biopsy was performed precisely 7 days after LH surge (LH+7)
| Study group | Role | What they receive |
|---|---|---|
| Endometrial biopsies | Experimental | Endometrial biopsy was performed precisely 7 days after LH surge (LH+7) to count endometrial CD138. Receives: Procedure: Endometrial biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
CD138 counting
Measured: 7 days after LH surge (LH+7)
clinical pregnancy rate
Measured: about 28 days after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start21 Mar 2016
- Primary completion1 Nov 2018
- Study completion2 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- 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
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reproductive & Genetic Hospital of CITIC-Xiangya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fei Gong, doctor, Principal investigator, Reproductive & Genetic Hospital of CITIC-Xiangya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03689101
- Sponsor's protocol ID
- P2018009
- Status last verified
- Jan 2022
- First submitted
- 21 Sep 2018
- Last updated
- 11 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Explore the Relationship Between Endometrial CD138 Count and Pregnancy Outcome Following Frozen Embryo Transfer in Natural Cycles
- ClinicalTrials.gov ID
- NCT03689101
- Acronym / sponsor ID
- P2018009
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Reproductive & Genetic Hospital of CITIC-XiangyaUniversity, hospital or other
- Study start
- 21 Mar 2016 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 2 Feb 2019 (actual)
- First posted
- 28 Sep 2018 (actual)
- 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.
It's well known, endometritis affects reproductive outcomes. Though CD138 counting as one new diagnosis measure for endometritis, diagnostic criterion of this measure isn't consistent. And if the CD138 counting is correlation to the outcome of reproductive is not clear.
Firstly, This study aims to explore the relationship between endometrial CD138 count and pregnancy outcome following frozen embryo transfer in natural cycles. Secondly , the investigators want to find a cut-off value which is related to reproduction outcome.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endometrial biopsies | Experimental | Procedure: Endometrial biopsiesEndometrial biopsy was performed precisely 7 days after LH surge (LH+7) to count endometrial CD138. |
Who may qualify
- Ages
- 20 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age between20 and 38 years;
- regular menstrual cycles;
- body mass index (BMI) ranged from 18 to 25
Key exclusion criteria (2 listed)
- uterine abnormalities;
- intrauterine adhesions（moderate - severe）, advanced endometriosis, adenomyosis, untreated hydrosalpinx, uterine fibroids (submucosal fibroids, nonmucosal fibroids >4.0 cm and/or endometrial pressure)
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 biopsiesEndometrial biopsy was performed precisely 7 days after LH surge (LH+7) | Procedure or surgery | Endometrial biopsies |
Primary outcome
CD138 counting
Time frame: 7 days after LH surge (LH+7)
clinical pregnancy rate
Time frame: about 28 days after embryo transfer
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 11 Jan 2022.
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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.
Fei Gong, doctor principal investigator
Reproductive & Genetic Hospital of CITIC-Xiangya
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 biopsies in people with Infertility, run by Reproductive & Genetic Hospital of CITIC-Xiangya 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 2 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 11 Jan 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?
CD138 counting (time frame: 7 days after LH surge (LH+7)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jan 2022.