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Mechanical Stimulation Improve the Fertilization in ICSI Cycle

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ClinicalTrials.gov Identifier: NCT03810001
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Tang-Du Hospital

Tracking Information
First Submitted Date  ICMJE January 7, 2019
First Posted Date  ICMJE January 18, 2019
Last Update Posted Date January 18, 2019
Actual Study Start Date  ICMJE November 11, 2018
Estimated Primary Completion Date June 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
Normal fertilization rate [ Time Frame: 6 months ]
2PN (two pronuclei and two polar bodies) rate
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
Feasibility and Efficacy of Mechanical Stimulation [ Time Frame: 6 months ]
Incidence of mechanical stimulation adverse events assessed by abnormally fertilization rate and oocytes degradation rate. Efficacy assessed by the exploitable embryo rate.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mechanical Stimulation Improve the Fertilization in ICSI Cycle
Official Title  ICMJE Use of Mechanical Stimulation to Active Oocytes Can Improve the Fertilization in Intracytoplasmic Sperm Injection Cycle
Brief 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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Fertilization
Intervention  ICMJE Behavioral: Mechanical Stimulation
micromanipulation technique before insertion of the microinjection needle into the oocyte and expulsion of the spermatozoon
Study Arms  ICMJE
  • No Intervention: standard ICSI procedure
    a single spermatozoon was injected into the ooplasm
  • Experimental: modified ICSI procedure
    slight mechanical stimulation before standard ICSI procedure
    Intervention: Behavioral: Mechanical Stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 17, 2019)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 20, 2019
Estimated Primary Completion Date June 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • oocytes number ≥ 8;
  • women undergoing intracytoplasmic sperm injection cycle.

Exclusion Criteria:

  • maturation oocytes number less than 6.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 22 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: wang ming 8613259809290 wangmingbio@snnu.edu.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03810001
Other Study ID Numbers  ICMJE 201801
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tang-Du Hospital
Study Sponsor  ICMJE Tang-Du Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: li bo Reproductive Medicine Center, Tangdu Hospital
PRS Account Tang-Du Hospital
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP