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

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ClinicalTrials.gov Identifier: NCT03810040
Recruitment Status : Not yet recruiting
First Posted : January 18, 2019
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Tang-Du Hospital

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
Embryo Device: 140 microns denuding pipette Device: 150 microns denuding pipette Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : November 2019

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




Primary Outcome Measures :
  1. quality of embryo [ Time Frame: one year ]
    embryo quality assessed by good embryo rate


Secondary Outcome Measures :
  1. clinical outcome - clinical prengancy rate [ Time Frame: three years ]
    clinical prengancy rate



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Ages Eligible for Study:   22 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • first cyele of IVF treatment

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03810040


Contacts
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Contact: wang ming 8613259809290 wangmingbio@snnu.edu.cn

Locations
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China, Shaanxi
Tangdu Hospital Recruiting
Xi'an, Shaanxi, China, 710038
Contact: wang ming         
Sponsors and Collaborators
Tang-Du Hospital
Investigators
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Study Director: jin ni Tang-Du Hospital

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Responsible Party: Tang-Du Hospital
ClinicalTrials.gov Identifier: NCT03810040     History of Changes
Other Study ID Numbers: 123456
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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