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

NCT ID: NCT03355937

Last Updated: 2017-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-12-31

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.

Conditions

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Unexplained Infertility Recurrent Implantation Failure

Keywords

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unexplained infertility recurrent implantation failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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UEI Sperm Chip (-)

Conventional IVF treatment and using conventional sperm selection

Group Type ACTIVE_COMPARATOR

Sperm Chip

Intervention Type PROCEDURE

Sperm selection using by conventional or with sperm chip

UEI Sperm Chip (+)

Conventional IVF treatment and using sperm chip for sperm selection

Group Type EXPERIMENTAL

Sperm Chip

Intervention Type PROCEDURE

Sperm selection using by conventional or with sperm chip

RIF sperm chip (-)

Conventional IVF treatment and using conventional sperm selection

Group Type ACTIVE_COMPARATOR

Sperm Chip

Intervention Type PROCEDURE

Sperm selection using by conventional or with sperm chip

RIF sperm chip (+)

Conventional IVF treatment and using sperm chip for sperm selection

Group Type EXPERIMENTAL

Sperm Chip

Intervention Type PROCEDURE

Sperm selection using by conventional or with sperm chip

Interventions

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Sperm Chip

Sperm selection using by conventional or with sperm chip

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Acibadem University

OTHER

Sponsor Role lead

Responsible Party

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Murat Dogan

Principal İnvestigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Acibadem Fulya Hospital

Istanbul, Besiktas, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Murat Dogan

Role: CONTACT

Phone: 00905056139577

Email: [email protected]

Ercan Bastu

Role: CONTACT

Phone: 00905324134195

Email: [email protected]

Facility Contacts

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Murat Dogan

Role: primary

References

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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.

Reference Type RESULT
PMID: 23677651 (View on PubMed)

Other Identifiers

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Ob&Gyn Fulya

Identifier Type: -

Identifier Source: org_study_id