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

Acibadem University

Status: Unknown

Conditions: Unexplained Infertility; Recurrent Implantation Failure

Treatments: Procedure: Sperm Chip

Study type: Interventional

Funder types: Other

Identifiers

NCT03355937

Ob&Gyn Fulya

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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200 participants in 4 patient groups

UEI Sperm Chip (-)

Active Comparator group

Description:

Conventional IVF treatment and using conventional sperm selection

Treatment:

Procedure: Sperm Chip

UEI Sperm Chip (+)

Experimental group

Description:

Conventional IVF treatment and using sperm chip for sperm selection

Treatment:

Procedure: Sperm Chip

RIF sperm chip (-)

Active Comparator group

Description:

Conventional IVF treatment and using conventional sperm selection

Treatment:

Procedure: Sperm Chip

RIF sperm chip (+)

Experimental group

Description:

Conventional IVF treatment and using sperm chip for sperm selection

Treatment:

Procedure: Sperm Chip