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Using Microfluidic Separation Sperm Selection for Unexplained Infertility and Reccurrent Implantation Failure

Primary Purpose

Unexplained Infertility, Recurrent Implantation Failure

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Sperm Chip
Sponsored by
Acibadem University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Unexplained Infertility focused on measuring unexplained infertility, recurrent implantation failure

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Unexplained Infertility Group; The inclusion criteria are;

  1. normal HSG,
  2. normal hormone levels,
  3. normal over functions,
  4. having normal uterine cavity and endometrial thickness determined by office hysteroscopy
  5. no endometriosis (determined by transvaginal ultrasonography and / or diagnostic laparoscopy)
  6. normal spermiogram result Recurrent Implantation Failure The inclusion criteria are;

1-The inclusion criteria of the working group are: 2-Failure of embryo transfer at least twice after high quality embryo transfer after 3-IVF treatment, 4-having normal hormone reserve (FSH <8 mIU / mL), 5-respond well to hormone stimulation (> 8 oocyte collection), 6-having normal uterine cavity and endometrial thickness determined by office hysteroscopy

Sites / Locations

  • Acibadem Fulya Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

UEI Sperm Chip (-)

UEI Sperm Chip (+)

RIF sperm chip (-)

RIF sperm chip (+)

Arm Description

Conventional IVF treatment and using conventional sperm selection

Conventional IVF treatment and using sperm chip for sperm selection

Conventional IVF treatment and using conventional sperm selection

Conventional IVF treatment and using sperm chip for sperm selection

Outcomes

Primary Outcome Measures

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.
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
Abortion Rate
Pregnancy loss includes miscarriage and therapeutic abor- tion of a clinical intrauterine pregnancy occurring at %20 weeks of gestation.
Implantation Rate
Implantation rate is the number of gestational sacs observed on ultrasonog- raphy, divided by the number of embryos transferred.

Secondary Outcome Measures

Full Information

First Posted
November 15, 2017
Last Updated
November 22, 2017
Sponsor
Acibadem University
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1. Study Identification

Unique Protocol Identification Number
NCT03355937
Brief Title
Using Microfluidic Separation Sperm Selection for Unexplained Infertility and Reccurrent Implantation Failure
Official Title
The Effects of Using Microfluidic Separation Sperm Selection for Unexplained Infertility(UEI) and Reccurrent Implantation Failure(RIF)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Anticipated)
Primary Completion Date
June 30, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Acibadem University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Patients will be treated with conventional IVF treatment. A vaginal ultrasound (US) examination will be perform on day 3 of the cycle for assessment of ovarian size and to exclude patients with large ovarian cysts. If a cyst >20 mm is present, the cycle will cancel. At an initial dose of 225 IU, hMG will be given daily by IM injection commencing on day 3 of the cycle. The dose will be adjusted as re- quired depending on the E2 (estradiol) level. Daily endovaginal US examinations for follicle growth assessment will be started when the E2 level reached 275 pg/mL (1,000 pmoljL). When at least two follicles would reach 18 mm in diameter, 5,000 IU of hCG will be administered intramuscularly. Oocyte retrieval will be performed vaginally under US guidance 36 hours later. Sperm for ICSI procedure of oocytes will be prepared by a standard swim-up technique using for control group and sperm chip method will be used for study group for Unexplained Infertility and Recurrent Implantation Failure group. Uterine transfer of embryos will be carry out fifth day after oocyte retrieval using a catheter.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unexplained Infertility, Recurrent Implantation Failure
Keywords
unexplained infertility, recurrent implantation failure

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
UEI Sperm Chip (-)
Arm Type
Active Comparator
Arm Description
Conventional IVF treatment and using conventional sperm selection
Arm Title
UEI Sperm Chip (+)
Arm Type
Experimental
Arm Description
Conventional IVF treatment and using sperm chip for sperm selection
Arm Title
RIF sperm chip (-)
Arm Type
Active Comparator
Arm Description
Conventional IVF treatment and using conventional sperm selection
Arm Title
RIF sperm chip (+)
Arm Type
Experimental
Arm Description
Conventional IVF treatment and using sperm chip for sperm selection
Intervention Type
Procedure
Intervention Name(s)
Sperm Chip
Intervention Description
Sperm selection using by conventional or with sperm chip
Primary Outcome Measure Information:
Title
Clinical Pregnancy Rate
Description
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.
Time Frame
36 month
Title
Live Birth Rate
Description
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
Time Frame
36 month
Title
Abortion Rate
Description
Pregnancy loss includes miscarriage and therapeutic abor- tion of a clinical intrauterine pregnancy occurring at %20 weeks of gestation.
Time Frame
36 month
Title
Implantation Rate
Description
Implantation rate is the number of gestational sacs observed on ultrasonog- raphy, divided by the number of embryos transferred.
Time Frame
36 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Unexplained Infertility Group; The inclusion criteria are; 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) normal spermiogram result Recurrent Implantation Failure The inclusion criteria are; 1-The inclusion criteria of the working group are: 2-Failure of embryo transfer at least twice after high quality embryo transfer after 3-IVF treatment, 4-having normal hormone reserve (FSH <8 mIU / mL), 5-respond well to hormone stimulation (> 8 oocyte collection), 6-having normal uterine cavity and endometrial thickness determined by office hysteroscopy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Murat Dogan
Phone
00905056139577
Email
muratdogan1984@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ercan Bastu
Phone
00905324134195
Email
dr.ercanbastu@yahoo.com
Facility Information:
Facility Name
Acibadem Fulya Hospital
City
Istanbul
State/Province
Besiktas
ZIP/Postal Code
34349
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Murat Dogan
Phone
005056139577
Email
muratdogan1984@gmail.com
First Name & Middle Initial & Last Name & Degree
Murat Dogan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23677651
Citation
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.
Results Reference
result

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Using Microfluidic Separation Sperm Selection for Unexplained Infertility and Reccurrent Implantation Failure

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