Mechanical Stimulation Improve the Fertilization in ICSI Cycle

Study Overview
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Brief Summary
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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
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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.

Official Title
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Use of Mechanical Stimulation to Active Oocytes Can Improve the Fertilization in Intracytoplasmic Sperm Injection Cycle

Conditions
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Fertilization

Intervention / Treatment
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* Behavioral: Mechanical Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: oocytes number ≥ 8; women undergoing intracytoplasmic sperm injection cycle. Exclusion Criteria: maturation oocytes number less than 6.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: standard ICSI procedure<br>a single spermatozoon was injected into the ooplasm | |
| Experimental: modified ICSI procedure<br>slight mechanical stimulation before standard ICSI procedure | Behavioral: Mechanical Stimulation<br>* micromanipulation technique before insertion of the microinjection needle into the oocyte and expulsion of the spermatozoon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normal fertilization rate | 2PN (two pronuclei and two polar bodies) rate | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oocyte activation, intracytoplasmic sperm injection(ICSI), mechanical stimulation, 2PN rate