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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

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.

Condition or disease Intervention/treatment Phase
Fertilization Behavioral: Mechanical Stimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Use of Mechanical Stimulation to Active Oocytes Can Improve the Fertilization in Intracytoplasmic Sperm Injection Cycle
Actual Study Start Date : November 11, 2018
Estimated Primary Completion Date : June 20, 2019
Estimated Study Completion Date : August 20, 2019

Arm Intervention/treatment
No Intervention: standard ICSI procedure
a single spermatozoon was injected into the ooplasm
Experimental: modified ICSI procedure
slight mechanical stimulation before standard ICSI procedure
Behavioral: Mechanical Stimulation
micromanipulation technique before insertion of the microinjection needle into the oocyte and expulsion of the spermatozoon




Primary Outcome Measures :
  1. Normal fertilization rate [ Time Frame: 6 months ]
    2PN (two pronuclei and two polar bodies) rate


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   22 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • maturation oocytes number less than 6.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03810001


Contacts
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Contact: wang ming 8613259809290 wangmingbio@snnu.edu.cn

Locations
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China, Shaanxi
Tangdu Hospital Recruiting
Xi'an, Shaanxi, China, 710038
Contact: wang ming         
Sponsors and Collaborators
Tang-Du Hospital
Investigators
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Study Chair: li bo Reproductive Medicine Center, Tangdu Hospital

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Responsible Party: Tang-Du Hospital
ClinicalTrials.gov Identifier: NCT03810001     History of Changes
Other Study ID Numbers: 201801
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tang-Du Hospital:
oocyte activation
intracytoplasmic sperm injection(ICSI)
mechanical stimulation
2PN rate