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Trial record 20 of 397 for:    Recruiting, Not yet recruiting, Available Studies | "Infertility"

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

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ClinicalTrials.gov Identifier: NCT03355937
Recruitment Status : Not yet recruiting
First Posted : November 29, 2017
Last Update Posted : November 29, 2017
Sponsor:
Information provided by (Responsible Party):
Murat Dogan, Acibadem University

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated 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)
Estimated Study Start Date : January 1, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

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




Primary Outcome Measures :
  1. Clinical Pregnancy Rate [ Time Frame: 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.

  2. Live Birth Rate [ Time Frame: 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

  3. Abortion Rate [ Time Frame: 36 month ]
    Pregnancy loss includes miscarriage and therapeutic abor- tion of a clinical intrauterine pregnancy occurring at %20 weeks of gestation.

  4. Implantation Rate [ Time Frame: 36 month ]
    Implantation rate is the number of gestational sacs observed on ultrasonog- raphy, divided by the number of embryos transferred.



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03355937


Contacts
Contact: Murat Dogan 00905056139577 muratdogan1984@gmail.com
Contact: Ercan Bastu 00905324134195 dr.ercanbastu@yahoo.com

Locations
Turkey
Acibadem Fulya Hospital Not yet recruiting
Istanbul, Besiktas, Turkey, 34349
Contact: Murat Dogan    005056139577    muratdogan1984@gmail.com   
Principal Investigator: Murat Dogan         
Sponsors and Collaborators
Acibadem University

Publications of Results:
Responsible Party: Murat Dogan, Principal İnvestigator, Acibadem University
ClinicalTrials.gov Identifier: NCT03355937     History of Changes
Other Study ID Numbers: Ob&Gyn Fulya
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Murat Dogan, Acibadem University:
unexplained infertility
recurrent implantation failure

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female