NCT03999762

Brief Summary

This clinical trial would be directed at determining the effectiveness of an innovative sperm sample preparation protocol for intrauterine insemination (IUI). The goal of the protocol would be to enable clinics not performing IUI to be able to perform IUI without requiring specialized training in sperm sample preparation.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

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

June 25, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2019

Completed
11 months until next milestone

Study Start

First participant enrolled

May 29, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

1 year

First QC Date

June 25, 2019

Last Update Submit

July 1, 2019

Conditions

Infertility

Outcome Measures

Primary Outcomes (3)

  • Total motile sperm count

    Total number of progressively motile sperm following sperm preparation

    At the time of sperm preparation

  • Percentage of patients with positive chemical pregnancy in each study group following IUI

    Detection of hCG

    2 weeks after IUI

  • Percentage of patients with positive clinical pregnancy in each study group following IUI

    Detection of the fetal heartbeat by ultrasound

    6 to 7 weeks after IUI

Study Arms (2)

Density gradient sample prep

ACTIVE COMPARATOR

Standard density gradient sample preparation

Device: sample prep

Automated sample prep

EXPERIMENTAL

Automated experimental sample preparation

Device: sample prep

Interventions

sample prepDEVICE

Effectiveness of a sample preparation protocol

Automated sample prepDensity gradient sample prep

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any couple with doctor's order for IUI with density gradient centrifugation

You may not qualify if:

  • Azoospermia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Raheel Samuel, PhD

    Nanonc Inc.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kenneth Aston, PhD

CONTACT

4357640911kiaston@utah.edu

Timothy Jenkins, PhD

CONTACT

8018855722tim.jenkins@hsc.utah.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2019

First Posted

June 27, 2019

Study Start

May 29, 2020

Primary Completion

May 31, 2021

Study Completion

November 30, 2021

Last Updated

July 5, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

IPD will not be shared with other researchers.