FertilizationNCT03810001
Mechanical Stimulation Improve the Fertilization in ICSI Cycle
A study testing Mechanical Stimulation in people with Fertilization, run by Tang-Du Hospital at 1 site in China.
Trial summary
Most fertilization failures after ICSI are caused by failure of oocyte activation defects. But, to date, there is no effective method to overcome this obstacle. To investigate the effect of mechanical stimulation on fertilization failures, investigators plan to recruit women undergoing ICSI treatment cycles. 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
- Fertilization
- What is being tested?
- Mechanical Stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 11 Nov 2018to 25 Dec 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
- oocytes number ≥ 8;
- women undergoing intracytoplasmic sperm injection cycle.
Who cannot join
- maturation oocytes number less than 6.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tangdu Hospital
Xi'an, Shaanxi, 710038
wang ming
About this study
Official title: Use of Mechanical Stimulation to Active Oocytes Can Improve the Fertilization in Intracytoplasmic Sperm Injection Cycle
Most fertilization failures after ICSI are caused by failure of oocyte activation defects. But, to date, there is no effective method to overcome this obstacle. To investigate the effect of mechanical stimulation on fertilization failures, investigators plan to recruit women undergoing ICSI treatment cycles. The retrieved sibling oocytes from the patients were randomly divided into two groups. The control group conducted the standard ICSI procedure, while the experimental group conducted the modified ICSI procedure.Consequently, the fertilization rate, 2PN (two pronuclei) rate, 1PN rate, oocyte degradation rate,and exploitable embryos on D3 were recorded to evaluate ICSI cycle outcomes.
Read the detailed description
Normal fertilization is the critical for the success of ICSI. To investigate the effect of mechanical stimulation on fertilization, investigators plan to recruit women undergoing ICSI treatment cycles. Exclusion criteria: Patients older than 40 years, the maturation oocytes less than 6. The retrieved sibling oocytes from the patient were randomly divided into two groups. The control group conducted the standard ICSI procedure, while the experimental group conducted the modified ICSI procedure. The modified ICSI procedure involved a micromanipulation mechanical stimulation between insertion of the microinjection needle into the oocyte and expulsion of the spermatozoon from the needle to the ooplasm, without additional reagents treatment. Consequently, the fertilization rate, 2PN rate, 1PN rate, oocyte degradation rate, and exploitable embryos on D3 were recorded. The investigators aim to evaluate whether the mechanical stimulation can be used to improve the normal fertilization and embryo quality in ICSI cycles.
- Conditions
- Fertilization
- Being tested
- Mechanical Stimulation
- Keywords
- oocyte activation, intracytoplasmic sperm injection(ICSI), mechanical stimulation, 2PN rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical StimulationBehavioural
micromanipulation technique before insertion of the microinjection needle into the oocyte and expulsion of the spermatozoon
| Study group | Role | What they receive |
|---|---|---|
| standard ICSI procedure | No intervention | a single spermatozoon was injected into the ooplasm |
| modified ICSI procedure | Experimental | slight mechanical stimulation before standard ICSI procedure Receives: Behavioral: Mechanical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normal fertilization rate
2PN (two pronuclei and two polar bodies) rate
Measured: 6 months
Secondary outcomes (1)
Feasibility and Efficacy of Mechanical Stimulation
Incidence of mechanical stimulation adverse events assessed by abnormally fertilization rate and oocytes degradation rate. Efficacy assessed by the exploitable embryo rate.
Measured: 6 months
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 start11 Nov 2018
- Primary completion20 Nov 2019 (estimated)
- Study completion25 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- li bo, Study chair, Reproductive Medicine Center, Tangdu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03810001
- Sponsor's protocol ID
- 201801
- Status last verified
- Sep 2019
- First submitted
- 7 Jan 2019
- Last updated
- 25 Sep 2019
- 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 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Mechanical Stimulation to Active Oocytes Can Improve the Fertilization in Intracytoplasmic Sperm Injection Cycle
- ClinicalTrials.gov ID
- NCT03810001
- Acronym / sponsor ID
- 201801
- Conditions
- Fertilization
- Keywords
- oocyte activation, intracytoplasmic sperm injection(ICSI), mechanical stimulation, 2PN rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 11 Nov 2018 (actual)
- Primary completion
- 20 Nov 2019 (estimated)
- Study completion
- 25 Dec 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.
Most fertilization failures after ICSI are caused by failure of oocyte activation defects. But, to date, there is no effective method to overcome this obstacle. To investigate the effect of mechanical stimulation on fertilization failures, investigators plan to recruit women undergoing ICSI treatment cycles. The retrieved sibling oocytes from the patients were randomly divided into two groups. The control group conducted the standard ICSI procedure, while the experimental group conducted the modified ICSI procedure.Consequently, the fertilization rate, 2PN (two pronuclei) rate, 1PN rate, oocyte degradation rate,and exploitable embryos on D3 were recorded to evaluate ICSI cycle outcomes.
Detailed description
Normal fertilization is the critical for the success of ICSI. To investigate the effect of mechanical stimulation on fertilization, investigators plan to recruit women undergoing ICSI treatment cycles. Exclusion criteria: Patients older than 40 years, the maturation oocytes less than 6. The retrieved sibling oocytes from the patient were randomly divided into two groups. The control group conducted the standard ICSI procedure, while the experimental group conducted the modified ICSI procedure. The modified ICSI procedure involved a micromanipulation mechanical stimulation between insertion of the microinjection needle into the oocyte and expulsion of the spermatozoon from the needle to the ooplasm, without additional reagents treatment. Consequently, the fertilization rate, 2PN rate, 1PN rate, oocyte degradation rate, and exploitable embryos on D3 were recorded. The investigators aim to evaluate whether the mechanical stimulation can be used to improve the normal fertilization and embryo quality in ICSI cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard ICSI procedure | No intervention | –a single spermatozoon was injected into the ooplasm |
| modified ICSI procedure | Experimental | Behavioral: Mechanical Stimulationslight mechanical stimulation before standard ICSI procedure |
Who may qualify
- Ages
- 22 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- oocytes number ≥ 8;
- women undergoing intracytoplasmic sperm injection cycle.
Key exclusion criteria (1 listed)
- maturation oocytes number less than 6.
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 |
|---|---|---|
| Mechanical Stimulationmicromanipulation technique before insertion of the microinjection needle into the oocyte and expulsion of the spermatozoon | Behavioural | modified ICSI procedure |
Primary outcome
Normal fertilization rate
Time frame: 6 months
2PN (two pronuclei and two polar bodies) rate
1 secondary outcome
Feasibility and Efficacy of Mechanical Stimulation
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
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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.
li bo study chair
Reproductive Medicine Center, Tangdu 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 Mechanical Stimulation in people with Fertilization, 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 2 inclusion and 1 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 25 Sep 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?
Normal fertilization rate (time frame: 6 months). 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 25 Sep 2019.