Clinical trial NCT03355937: Using Microfluidic Separation Sperm Selection for Unexplained Infertility and Reccurrent Implantation Failure
Official title: The Effects of Using Microfluidic Separation Sperm Selection for Unexplained Infertility(UEI) and Reccurrent Implantation Failure(RIF)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Unexplained Infertility
Recurrent Implantation Failure
Keywords: unexplained infertility
recurrent implantation failure
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2017-11-29
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

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.

Eligibility 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

Primary outcomes:
measure: Clinical Pregnancy Rate
timeFrame: 36 month
measure: Live Birth Rate
timeFrame: 36 month
measure: Abortion Rate
timeFrame: 36 month
measure: Implantation Rate
timeFrame: 36 month
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acibadem Fulya Hospital
state: Besiktas
Study officials:
References:
citation: 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.