NCT03810040

Brief Summary

Good-quality embryos are critical for the success of in vitro fertilization (IVF). But, to date, there is no report of the effect of different diameters denuding pipette on the embryos quality. To investigate the effect of denuding pipette in IVF outcomes, we plan to recruit women undergoing IVF treatment cycles and classified them into two groups according to the different diameters. Consequently, the rate of fertilization, zygotes cleaved, top quality embryos on D3, and blastocysts obtained were recorded.

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
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2018

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 18, 2019

Completed
14 days until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

January 18, 2019

Status Verified

January 1, 2019

Enrollment Period

3 months

First QC Date

July 5, 2018

Last Update Submit

January 17, 2019

Conditions

Embryo

Keywords

Embryos qualityIn vitro fertilizationDenuding pipette

Outcome Measures

Primary Outcomes (1)

  • quality of embryo

    embryo quality assessed by good embryo rate

    one year

Secondary Outcomes (1)

  • clinical outcome - clinical prengancy rate

    three years

Study Arms (2)

Odd-numbered days

ACTIVE COMPARATOR

Once odd-numbered days the zytoges of IVF cycle were collected. The 140 microns denuding pipette was used.

Device: 140 microns denuding pipette

Even-numbered days

EXPERIMENTAL

Once even-numbered days the zytoges of IVF cycle were collected. The 150 microns denuding pipette was used.

Device: 150 microns denuding pipette

Interventions

140 microns denuding pipetteDEVICE

the degranulated needle size was 140 microns

Odd-numbered days
150 microns denuding pipetteDEVICE

the degranulated needle size was 150 microns

Even-numbered days

Eligibility Criteria

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

You may qualify if:

  • first cyele of IVF treatment

You may not qualify if:

  • oocyte number less than 4
  • oocyte number over than 25

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tangdu Hospital

Xi'an, Shaanxi, 710038, China

Location

Study Officials

  • jin ni

    Tang-Du Hospital

    STUDY DIRECTOR

Central Study Contacts

wang ming

CONTACT

8613259809290wangmingbio@snnu.edu.cn

Study Design

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

Study Record Dates

First Submitted

July 5, 2018

First Posted

January 18, 2019

Study Start

February 1, 2019

Primary Completion

May 1, 2019

Study Completion

November 1, 2019

Last Updated

January 18, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)