Mechanical Stimulation Improve the Fertilization in ICSI Cycle

NCT ID: NCT03810001

Last Updated: 2019-09-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-11
• Study Completion Date: 2019-12-25

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.

Conditions

Fertilization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

standard ICSI procedure

a single spermatozoon was injected into the ooplasm

Group Type: NO_INTERVENTION

No interventions assigned to this group

modified ICSI procedure

slight mechanical stimulation before standard ICSI procedure

Group Type: EXPERIMENTAL

Mechanical Stimulation

Intervention Type: BEHAVIORAL

micromanipulation technique before insertion of the microinjection needle into the oocyte and expulsion of the spermatozoon

Interventions

Mechanical Stimulation

micromanipulation technique before insertion of the microinjection needle into the oocyte and expulsion of the spermatozoon

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• maturation oocytes number less than 6.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Tang-Du Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

li bo

Role: STUDY_CHAIR

Reproductive Medicine Center, Tangdu Hospital

Locations

Tangdu Hospital

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

wang ming

Role: CONTACT

wangmingbio@snnu.edu.cn

8613259809290

Facility Contacts

wang ming

Role: primary

Other Identifiers

201801

Identifier Type: -

Identifier Source: org_study_id