NCT02749773

Brief Summary

The aim of this study is to determine whether different needle gauges influences the quality of the aspirated oocytes during in-vivo fertilization (IVF).

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

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

April 6, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 25, 2016

Completed
6 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 3, 2016

Status Verified

May 1, 2016

Enrollment Period

1 year

First QC Date

April 6, 2016

Last Update Submit

May 1, 2016

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Oocyte Quality microscopic description.

    Aspirated oocytes from both needle gauges will be compared for quality according to 5 parameters: Polar body, Zona pellucida, Dark cytoplasm, Perivitelline space and Vacuoles.

    One year

Study Arms (2)

Oocyte aspiration with 17G needle

ACTIVE COMPARATOR

Oocyte Aspiration with 17G needle.

Device: Oocyte Aspiration needle

Oocyte aspiration with (20-17G) needle

ACTIVE COMPARATOR

Oocyte Aspiration (20-17G) needle.

Device: Oocyte Aspiration needle

Interventions

Oocyte Aspiration needleDEVICE

Oocyte aspiration in women go through an IVF procedure,.

Oocyte aspiration with (20-17G) needleOocyte aspiration with 17G needle

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Fertility treatment
  • Antral follicle count

You may not qualify if:

  • Women who refuse to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

Related Publications (1)

  • Atzmon Y, Michaeli M, Aslih N, Ruzov O, Rotfarb N, Shoshan-Karchovsky E, Shalom-Paz E. Degenerative Oocytes in the Aspirated Cohort Are Not Due to the Aspirating Needle: a Prospective Randomized Pilot Study with Sibling Oocytes. Reprod Sci. 2021 Jul;28(7):1882-1889. doi: 10.1007/s43032-020-00384-3. Epub 2020 Nov 10.

    PMID: 33171516DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Yuval Atzmon, MD

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuval Atzmon, MD

CONTACT

atzmony@gmail.com

Study Design

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

Study Record Dates

First Submitted

April 6, 2016

First Posted

April 25, 2016

Study Start

May 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

May 3, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)