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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Unexplained Infertility, Recurrent Implantation Failure

Intervention / Treatment
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* Procedure: Sperm Chip


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unexplained infertility, recurrent implantation failure