EmbryoNCT03810040
Effect of Degranulation Needle With Different Diameters on the Rate Good Embryo in IVF
A study testing 140 microns denuding pipette and 150 microns denuding pipette in people with Embryo, run by Tang-Du Hospital at 1 site in China.
Trial summary
Good-quality embryos are critical for the success of in vitro fertilization (IVF). But, to date, there is no report of the effect of different diameters denuding pipette on the embryos quality. Read more about this study
- Who is it for?
- Ages 22 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Embryo
- What is being tested?
- 140 microns denuding pipette and 150 microns denuding pipette
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Feb 2019to Nov 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 22 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- first cyele of IVF treatment
Who cannot join
- oocyte number less than 4
- oocyte number over than 25
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Degranulation Needle on the Rate Good Embryo in IVF
Good-quality embryos are critical for the success of in vitro fertilization (IVF). But, to date, there is no report of the effect of different diameters denuding pipette on the embryos quality. To investigate the effect of denuding pipette in IVF outcomes, we plan to recruit women undergoing IVF treatment cycles and classified them into two groups according to the different diameters. Consequently, the rate of fertilization, zygotes cleaved, top quality embryos on D3, and blastocysts obtained were recorded.
Read the detailed description
Good-quality embryos are critical for the success of in vitro fertilization (IVF). But, to date, there is no report of the effect of different diameters denuding pipette on the embryos quality. To investigate the effect of denuding pipette in IVF outcomes, we plan to recruit women undergoing IVF treatment cycles and classified them into two groups according to the different diameters. The participants were divided into two group. Odd-numbered days the zygotes were degranulated with the 140 microns needles. Even-numbered days the zygotes were degranulated with the 150 microns needles. Consequently, the rate of fertilization, zygotes cleaved, top quality embryos on D3, and blastocysts obtained were recorded.
- Conditions
- Embryo
- Being tested
- 140 microns denuding pipette, 150 microns denuding pipette
- Keywords
- Embryos quality, In vitro fertilization, Denuding pipette
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
140 microns denuding pipetteDevice
the degranulated needle size was 140 microns
150 microns denuding pipetteDevice
the degranulated needle size was 150 microns
| Study group | Role | What they receive |
|---|---|---|
| Odd-numbered days | Active comparator | Once odd-numbered days the zytoges of IVF cycle were collected. The 140 microns denuding pipette was used. Receives: Device: 140 microns denuding pipette |
| Even-numbered days | Experimental | Once even-numbered days the zytoges of IVF cycle were collected. The 150 microns denuding pipette was used. Receives: Device: 150 microns denuding pipette |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of embryo
embryo quality assessed by good embryo rate
Measured: one year
Secondary outcomes (1)
clinical outcome - clinical prengancy rate
clinical prengancy rate
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study startFeb 2019 (estimated)
- Primary completionMay 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmbryoStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jin ni, Study director, Tang-Du Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03810040
- Sponsor's protocol ID
- 123456
- Status last verified
- Jan 2019
- First submitted
- 5 Jul 2018
- Last updated
- 18 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Degranulation Needle on the Rate Good Embryo in IVF
- ClinicalTrials.gov ID
- NCT03810040
- Acronym / sponsor ID
- 123456
- Conditions
- Embryo
- Keywords
- Embryos quality, In vitro fertilization, Denuding pipette
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- Feb 2019 (estimated)
- Primary completion
- May 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 18 Jan 2019 (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.
Good-quality embryos are critical for the success of in vitro fertilization (IVF). But, to date, there is no report of the effect of different diameters denuding pipette on the embryos quality. To investigate the effect of denuding pipette in IVF outcomes, we plan to recruit women undergoing IVF treatment cycles and classified them into two groups according to the different diameters. Consequently, the rate of fertilization, zygotes cleaved, top quality embryos on D3, and blastocysts obtained were recorded.
Detailed description
Good-quality embryos are critical for the success of in vitro fertilization (IVF). But, to date, there is no report of the effect of different diameters denuding pipette on the embryos quality. To investigate the effect of denuding pipette in IVF outcomes, we plan to recruit women undergoing IVF treatment cycles and classified them into two groups according to the different diameters. The participants were divided into two group. Odd-numbered days the zygotes were degranulated with the 140 microns needles. Even-numbered days the zygotes were degranulated with the 150 microns needles. Consequently, the rate of fertilization, zygotes cleaved, top quality embryos on D3, and blastocysts obtained were recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Odd-numbered days | Active comparator | Device: 140 microns denuding pipetteOnce odd-numbered days the zytoges of IVF cycle were collected. The 140 microns denuding pipette was used. |
| Even-numbered days | Experimental | Device: 150 microns denuding pipetteOnce even-numbered days the zytoges of IVF cycle were collected. The 150 microns denuding pipette was used. |
Who may qualify
- Ages
- 22 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- first cyele of IVF treatment
Key exclusion criteria (2 listed)
- oocyte number less than 4
- oocyte number over than 25
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 |
|---|---|---|
| 140 microns denuding pipettethe degranulated needle size was 140 microns | Device | Odd-numbered days |
| 150 microns denuding pipettethe degranulated needle size was 150 microns | Device | Even-numbered days |
Primary outcome
quality of embryo
Time frame: one year
embryo quality assessed by good embryo rate
1 secondary outcome
clinical outcome - clinical prengancy rate
Time frame: three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2019.
- 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.
jin ni study director
Tang-Du 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 140 microns denuding pipette and 150 microns denuding pipette in people with Embryo, run by Tang-Du Hospital 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 1 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: status not confirmed, as of the sponsor's last update on 18 Jan 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact wang ming (8613259809290, wangmingbio@snnu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of embryo (time frame: one year). 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 18 Jan 2019.