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

Sponsor

Acibadem University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03355937

Collaborator

(none)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

8.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Unexplained Infertility Recurrent Implantation Failure	Procedure: Sperm Chip	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Screening

Official Title:

The Effects of Using Microfluidic Separation Sperm Selection for Unexplained Infertility(UEI) and Reccurrent Implantation Failure(RIF)

Anticipated Study Start Date :

Jan 1, 2018

Anticipated Primary Completion Date :

Jun 30, 2019

Anticipated Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: UEI Sperm Chip (-) Conventional IVF treatment and using conventional sperm selection	Procedure: Sperm Chip Sperm selection using by conventional or with sperm chip
Experimental: UEI Sperm Chip (+) Conventional IVF treatment and using sperm chip for sperm selection	Procedure: Sperm Chip Sperm selection using by conventional or with sperm chip
Active Comparator: RIF sperm chip (-) Conventional IVF treatment and using conventional sperm selection	Procedure: Sperm Chip Sperm selection using by conventional or with sperm chip
Experimental: RIF sperm chip (+) Conventional IVF treatment and using sperm chip for sperm selection	Procedure: Sperm Chip Sperm selection using by conventional or with sperm chip

Outcome Measures

Primary Outcome Measures

Clinical Pregnancy Rate [36 month]
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 [36 month]
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 [36 month]
Pregnancy loss includes miscarriage and therapeutic abor- tion of a clinical intrauterine pregnancy occurring at %20 weeks of gestation.
Implantation Rate [36 month]
Implantation rate is the number of gestational sacs observed on ultrasonog- raphy, divided by the number of embryos transferred.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Acibadem Fulya Hospital	Istanbul	Besiktas	Turkey	34349

Sponsors and Collaborators

Acibadem University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Murat Dogan, Principal İnvestigator, Acibadem University

ClinicalTrials.gov Identifier:

NCT03355937

Other Study ID Numbers:

Ob&Gyn Fulya

First Posted:

Nov 29, 2017

Last Update Posted:

Nov 29, 2017

Last Verified:

Nov 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Murat Dogan, Principal İnvestigator, Acibadem University

unexplained infertility

recurrent implantation failure

Additional relevant MeSH terms:

Infertility

Study Results

No Results Posted as of Nov 29, 2017