NCT03810001

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 18, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2019

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

1 year

First QC Date

January 7, 2019

Last Update Submit

September 24, 2019

Conditions

Fertilization

Keywords

oocyte activationintracytoplasmic sperm injection(ICSI)mechanical stimulation2PN rate

Outcome Measures

Primary Outcomes (1)

  • Normal fertilization rate

    2PN (two pronuclei and two polar bodies) rate

    6 months

Secondary Outcomes (1)

  • Feasibility and Efficacy of Mechanical Stimulation

    6 months

Study Arms (2)

standard ICSI procedure

NO INTERVENTION

a single spermatozoon was injected into the ooplasm

modified ICSI procedure

EXPERIMENTAL

slight mechanical stimulation before standard ICSI procedure

Behavioral: Mechanical Stimulation

Interventions

Mechanical StimulationBEHAVIORAL

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

modified ICSI procedure

Eligibility Criteria

Age22 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • maturation oocytes number less than 6.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tangdu Hospital

Xi'an, Shaanxi, 710038, China

RECRUITING

Study Officials

  • li bo

    Reproductive Medicine Center, Tangdu Hospital

    STUDY CHAIR

Central Study Contacts

wang ming

CONTACT

8613259809290wangmingbio@snnu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2019

First Posted

January 18, 2019

Study Start

November 11, 2018

Primary Completion

November 20, 2019

Study Completion

December 25, 2019

Last Updated

September 25, 2019

Record last verified: 2019-09

Locations

CN(1)