Mechanical Stimulation Improve the Fertilization in ICSI Cycle

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03810001

Enrollment

500

Registered

2019-01-18

Start date

2018-11-11

Completion date

2019-12-25

Last updated

2019-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fertilization

Keywords

oocyte activation, intracytoplasmic sperm injection(ICSI), mechanical stimulation, 2PN rate

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.

Interventions

BEHAVIORALMechanical Stimulation

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

22 Years to 35 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* maturation oocytes number less than 6.

Design outcomes

Primary

Measure	Time frame	Description
Normal fertilization rate	6 months	2PN (two pronuclei and two polar bodies) rate

Secondary

Measure	Time frame	Description
Feasibility and Efficacy of Mechanical Stimulation	6 months	Incidence of mechanical stimulation adverse events assessed by abnormally fertilization rate and oocytes degradation rate. Efficacy assessed by the exploitable embryo rate.

Countries

China

Contacts

Primary Contactwang ming

wangmingbio@snnu.edu.cn8613259809290

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026