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Effect of Degranulation Needle With Different Diameters on the Rate Good Embryo in IVF

Sponsor
Tang-Du Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03810040
Collaborator
(none)
400
Enrollment
1
Location
2
Arms
9
Anticipated Duration (Months)
44.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: 140 microns denuding pipette
  • Device: 150 microns denuding pipette
 N/A

Detailed Description

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. The participants were divided into two group. Odd-numbered days the zygotes were degranulated with the 140 microns needles. Even-numbered days the zygotes were degranulated with the 150 microns needles. Consequently, the rate of fertilization, zygotes cleaved, top quality embryos on D3, and blastocysts obtained were recorded.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
Effect of Degranulation Needle on the Rate Good Embryo in IVF
Anticipated Study Start Date :
Feb 1, 2019
Anticipated Primary Completion Date :
May 1, 2019
Anticipated Study Completion Date :
Nov 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Odd-numbered days

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

Device: 140 microns denuding pipette
the degranulated needle size was 140 microns
Experimental: Even-numbered days

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

Device: 150 microns denuding pipette
the degranulated needle size was 150 microns

Outcome Measures

Primary Outcome Measures

  1. quality of embryo [one year]

    embryo quality assessed by good embryo rate

Secondary Outcome Measures

  1. clinical outcome - clinical prengancy rate [three years]

    clinical prengancy rate

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years to 35 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • first cyele of IVF treatment
Exclusion Criteria:

  • oocyte number less than 4

  • oocyte number over than 25

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tangdu Hospital Xi'an Shaanxi China 710038

Sponsors and Collaborators

  • Tang-Du Hospital

Investigators

  • Study Director: jin ni, Tang-Du Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tang-Du Hospital
ClinicalTrials.gov Identifier:
NCT03810040
Other Study ID Numbers:
  • 123456
First Posted:
Jan 18, 2019
Last Update Posted:
Jan 18, 2019
Last Verified:
Jan 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tang-Du Hospital
Embryos quality
In vitro fertilization
Denuding pipette

Study Results

No Results Posted as of Jan 18, 2019