Mechanical Stimulation Improve the Fertilization in ICSI Cycle

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.

Study Overview

• Status: Unknown
• Conditions: Fertilization
• Intervention / Treatment: Behavioral: Mechanical Stimulation

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: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710038
      • Recruiting
      • Tangdu Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

• maturation oocytes number less than 6.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tang-Du Hospital
• Investigators: Study Chair: li bo, Reproductive Medicine Center, Tangdu Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 11, 2018
• Primary Completion (ANTICIPATED): November 20, 2019
• Study Completion (ANTICIPATED): December 25, 2019

Study Registration Dates

• First Submitted: January 7, 2019
• First Submitted That Met QC Criteria: January 17, 2019
• First Posted (ACTUAL): January 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 25, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: oocyte activation; intracytoplasmic sperm injection(ICSI); mechanical stimulation; 2PN rate
• Other Study ID Numbers: 201801

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No