Mechanical Stimulation Improve the Fertilization in ICSI Cycle

Fertilization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03810001
• Other study ID #: 201801
• Status: Recruiting
• Phase: N/A
• Start date: November 11, 2018
• Est. completion date: December 25, 2019

Study information

• Verified date: September 2019
• Source: Tang-Du Hospital
• Contact: wang ming
• Phone: 8613259809290
• Email: wangmingbio[@]snnu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 25, 2019
• Est. primary completion date: November 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 22 Years to 35 Years

Eligibility

Inclusion Criteria:

• oocytes number = 8;

• women undergoing intracytoplasmic sperm injection cycle.

Exclusion Criteria:

• maturation oocytes number less than 6.

Related Conditions & MeSH terms

• Fertilization

Intervention

Behavioral:
• Mechanical Stimulation
micromanipulation technique before insertion of the microinjection needle into the oocyte and expulsion of the spermatozoon

Locations

Country	Name	City	State
China	Tangdu Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Tang-Du Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Normal fertilization rate	2PN (two pronuclei and two polar bodies) rate	6 months
Secondary	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