NCT03355937

Brief Summary

In order to increase the likelihood of achieving IVF-treated pregnancy, good quality embryo transfer is important. To get good quality embryos, good quality gametes are needed. The selection of sperm is regulated according to the changing and mobility characteristics of today's conditions. The choice of multi-fluid sperm is thought to provide better sperm to obtain the environment in physiological conditions. Better embryo transfer to achieve better sperm elongation will increase the likelihood of pregnancy.

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
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration 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

November 15, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 29, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

November 29, 2017

Status Verified

November 1, 2017

Enrollment Period

1.5 years

First QC Date

November 15, 2017

Last Update Submit

November 22, 2017

Conditions

Unexplained InfertilityRecurrent Implantation Failure

Keywords

unexplained infertilityrecurrent implantation failure

Outcome Measures

Primary Outcomes (4)

  • Clinical Pregnancy Rate

    Clinical pregnancy includes intrauterine gestation (pres- ence of a gestational sac on ultrasonography), ectopic preg- nancy, and miscarriage diagnosed by histology.Cycles with only a positive pregnancy test (biochemical pregnancy) are not considered to have a clinical pregnancy.

    36 month

  • Live Birth Rate

    A delivery is the birth of one or more infants, either living or not, after 20 weeks of gestation. A live birth is a delivery that results in at least one living infant

    36 month

  • Abortion Rate

    Pregnancy loss includes miscarriage and therapeutic abor- tion of a clinical intrauterine pregnancy occurring at %20 weeks of gestation.

    36 month

  • Implantation Rate

    Implantation rate is the number of gestational sacs observed on ultrasonog- raphy, divided by the number of embryos transferred.

    36 month

Study Arms (4)

UEI Sperm Chip (-)

ACTIVE COMPARATOR

Conventional IVF treatment and using conventional sperm selection

Procedure: Sperm Chip

UEI Sperm Chip (+)

EXPERIMENTAL

Conventional IVF treatment and using sperm chip for sperm selection

Procedure: Sperm Chip

RIF sperm chip (-)

ACTIVE COMPARATOR

Conventional IVF treatment and using conventional sperm selection

Procedure: Sperm Chip

RIF sperm chip (+)

EXPERIMENTAL

Conventional IVF treatment and using sperm chip for sperm selection

Procedure: Sperm Chip

Interventions

Sperm ChipPROCEDURE

Sperm selection using by conventional or with sperm chip

RIF sperm chip (+)RIF sperm chip (-)UEI Sperm Chip (+)UEI Sperm Chip (-)

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • normal HSG,
  • normal hormone levels,
  • normal over functions,
  • having normal uterine cavity and endometrial thickness determined by office hysteroscopy
  • no endometriosis (determined by transvaginal ultrasonography and / or diagnostic laparoscopy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acibadem Fulya Hospital

Istanbul, Besiktas, 34349, Turkey (Türkiye)

Location

Related Publications (1)

  • Tasoglu S, Safaee H, Zhang X, Kingsley JL, Catalano PN, Gurkan UA, Nureddin A, Kayaalp E, Anchan RM, Maas RL, Tuzel E, Demirci U. Exhaustion of racing sperm in nature-mimicking microfluidic channels during sorting. Small. 2013 Oct 25;9(20):3374-84. doi: 10.1002/smll.201300020. Epub 2013 May 16.

    PMID: 23677651RESULT

Central Study Contacts

Murat Dogan

CONTACT

00905056139577muratdogan1984@gmail.com

Ercan Bastu

CONTACT

00905324134195dr.ercanbastu@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SCREENING
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal İnvestigator

Study Record Dates

First Submitted

November 15, 2017

First Posted

November 29, 2017

Study Start

January 1, 2018

Primary Completion

June 30, 2019

Study Completion

December 31, 2019

Last Updated

November 29, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)