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

Not Applicable

• Conditions: Unexplained Infertility; Recurrent Implantation Failure
• Interventions: Procedure: Sperm Chip

• Registration Number: NCT03355937
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2017-11
• Study First Submitted: 2017-11-15
• Study First Submitted QC: 2017-11-22
• Last Update Submitted: 2017-11-22
• Study First Posted: 2017-11-29
• Last Update Posted: 2017-11-29
• Study Start: 2018-01-01
• Primary Completion: 2019-06-30
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
RIF sperm chip (-)	Sperm Chip	Conventional IVF treatment and using conventional sperm selection
RIF sperm chip (+)	Sperm Chip	Conventional IVF treatment and using sperm chip for sperm selection
UEI Sperm Chip (-)	Sperm Chip	Conventional IVF treatment and using conventional sperm selection
UEI Sperm Chip (+)	Sperm Chip	Conventional IVF treatment and using sperm chip for sperm selection

Primary Outcome Measures

Name	Time	Method
Implantation Rate	36 month	Implantation rate is the number of gestational sacs observed on ultrasonog- raphy, divided by the number of embryos transferred.
Clinical Pregnancy Rate	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.
Live Birth Rate	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
Abortion Rate	36 month	Pregnancy loss includes miscarriage and therapeutic abor- tion of a clinical intrauterine pregnancy occurring at %20 weeks of gestation.

Trial Locations

Locations (1)

Acibadem Fulya Hospital; 🇹🇷 Istanbul, Besiktas, Turkey