in Vitro FertilizationNCT03728140
Embryo Transfer With Self-spent Culture Medium
A study testing Self-spent Culture Medium in people with in Vitro Fertilization, run by Bin Wu at 1 site in China.
Trial summary
Embryo Transfer With Self-spent Culture Medium or new Culture Medium in Vitro Fertilization - Embryo Transfer Process, to analyze which way can improve clinical pregnancy outcomes, is there a significant difference between the two? Read more about this study
- Who is it for?
- Ages 25 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- in Vitro Fertilization
- What is being tested?
- Self-spent Culture Medium
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 335 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Infertility female patients with tubal factors,
- Infertile female patients with spouse factors
Who cannot join
- Intrauterine adhesions,
- Endometriosis,
- Primary ovarian insufficiency，
- Infectious disease
Trial locations and contacts
1 site in 1 country.
China1 site
Jinan Central Hospital Affiliated to Shandong University
Jinan, Shandong, 250013
About this study
Official title: Can Embryo Transfer With Self-spent Culture Medium Improve Clinical Pregnancy Outcomes in Vitro Fertilization - Embryo Transfer Process?
Embryo Transfer With Self-spent Culture Medium or new Culture Medium in Vitro Fertilization - Embryo Transfer Process, to analyze which way can improve clinical pregnancy outcomes, is there a significant difference between the two?
Read the detailed description
Although some metabolites are present in self-spent culture medium, there are some embryonic exocrine factors secreted by embryo.These factors may have a positive impact on embryo implantation and subsequent development. So it is necessary to compare the two ways of embryo transfer with Self-spent Culture Medium or New Culture Medium in vitro fertilization - embryo transfer process.
The purpose of this study is to analyze which way can improve clinical pregnancy and birth outcomes, is there a significant difference between the two?
- Conditions
- in Vitro Fertilization
- Being tested
- Self-spent Culture Medium
- Keywords
- Embryo Transfer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-spent Culture MediumProcedure or surgery
Replace embryo transfer solution with Self-spent culture medium in IVF-ET.
| Study group | Role | What they receive |
|---|---|---|
| Self-spent Culture Medium | Experimental | Changing embryo transfer solution with self-spent culture medium Receives: Procedure: Self-spent Culture Medium |
| New Culture Medium | No intervention | embryo transfer with new culture medium in IVF-ET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Pregnant After 4 Weeks
Observe the clinical pregnancy rate under different embryo transfer methods
Measured: 4 weeks
Live Birth
Observe the live birth rate under different embryo transfer methods
Measured: 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start1 Jan 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for in Vitro FertilizationStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 335 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bin Wu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bin Wu, Jinan Central Hospital
- Investigators
- Yingchun zhang, Dr, Study director, Jinan Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03728140
- Sponsor's protocol ID
- JianCH-RM001
- Status last verified
- Dec 2019
- First submitted
- 29 Oct 2018
- Last updated
- 27 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Embryo Transfer With Self-spent Culture Medium Improve Clinical Pregnancy Outcomes in Vitro Fertilization - Embryo Transfer Process?
- ClinicalTrials.gov ID
- NCT03728140
- Acronym / sponsor ID
- JianCH-RM001
- Conditions
- in Vitro Fertilization
- Keywords
- Embryo Transfer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 335 participants (actual)
- Lead sponsor
- Bin WuUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 1 Nov 2018 (actual)
- Results
- Posted 27 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Embryo Transfer With Self-spent Culture Medium or new Culture Medium in Vitro Fertilization - Embryo Transfer Process, to analyze which way can improve clinical pregnancy outcomes, is there a significant difference between the two?
Detailed description
Although some metabolites are present in self-spent culture medium, there are some embryonic exocrine factors secreted by embryo.These factors may have a positive impact on embryo implantation and subsequent development. So it is necessary to compare the two ways of embryo transfer with Self-spent Culture Medium or New Culture Medium in vitro fertilization - embryo transfer process.
The purpose of this study is to analyze which way can improve clinical pregnancy and birth outcomes, is there a significant difference between the two?
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-spent Culture Medium | Experimental | Procedure: Self-spent Culture MediumChanging embryo transfer solution with self-spent culture medium |
| New Culture Medium | No intervention | –embryo transfer with new culture medium in IVF-ET |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Infertility female patients with tubal factors,
- Infertile female patients with spouse factors
Key exclusion criteria (4 listed)
- Intrauterine adhesions,
- Endometriosis,
- Primary ovarian insufficiency，
- Infectious disease
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 |
|---|---|---|
| Self-spent Culture MediumReplace embryo transfer solution with Self-spent culture medium in IVF-ET. | Procedure or surgery | Self-spent Culture Medium |
Primary outcome
Number of Participants Pregnant After 4 Weeks
Time frame: 4 weeks
Observe the clinical pregnancy rate under different embryo transfer methods
Live Birth
Time frame: 40 weeks
Observe the live birth rate under different embryo transfer methods
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Yingchun zhang, Dr study director
Jinan Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-spent Culture Medium in people with in Vitro Fertilization, run by Bin Wu 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 2 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 27 Jan 2020. 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?
Yes. Results are posted in the registry (first posted 27 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Pregnant After 4 Weeks (time frame: 4 weeks). 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 27 Jan 2020.