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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03355937
Enrollment
200
Registered
2017-11-29
Start date
2018-01-01
Completion date
2019-12-31
Last updated
2017-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Implantation Failure, Unexplained Infertility

Keywords

unexplained infertility, recurrent implantation failure

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.

Interventions

PROCEDURESperm Chip

Sperm selection using by conventional or with sperm chip

Sponsors

Acibadem University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Clinical Pregnancy Rate36 monthClinical 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 Rate36 monthA 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 Rate36 monthPregnancy loss includes miscarriage and therapeutic abor- tion of a clinical intrauterine pregnancy occurring at %20 weeks of gestation.
Implantation Rate36 monthImplantation rate is the number of gestational sacs observed on ultrasonog- raphy, divided by the number of embryos transferred.

Countries

Turkey (Türkiye)

Contacts

Primary ContactMurat Dogan
muratdogan1984@gmail.com00905056139577
Backup ContactErcan Bastu
dr.ercanbastu@yahoo.com00905324134195

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026