The Effects of Using Fertile Chip in Sperm Selection for Intracytoplasmic Sperm Injection in Unexplained Infertility

Baskent University

Status and phase: Completed; Phase 3

Conditions: Unexplained Infertility

Treatments: Device: fertile chip

Study type: Interventional

Funder types: Other

Identifiers

NCT02488434

KA15/132

Details and patient eligibility

About

The aim of the current study is to evaluate to effectiveness of sperm selection by using fertile chip in unexplained infertile couples on intracytoplasmic sperm injection (ICSI) cycles.

Full description

The aim of the current study is to evaluate to effectiveness of sperm selection by using fertile chip in unexplained infertile couples on intracytoplasmic sperm injection (ICSI) cycles. On study arm sperm selection will be performed by using special microchannel system which is called fertile chip (FC) without using sperm wash procedure. This FC system leads to select lineer motile progressive sperm selection. In control group, sperm selection will be performed by classical way which sperm will be undertaken to sperm wash by gradient method.

After selection of sperm in both arms, ICSI will be performed. The outcomes of ICSI schedule will be assesed by fertilization and clinical pregnancy rates.

Enrollment: 122 patients

Sex: All

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• between 20-37 year-old women
• normal tubal patency, normal uterine cavity, normal ovulation,
• between 20-40 year-old men
• normal semen analyse by WHO criterias
• unexplained infertile couples

Exclusion criteria

• poor ovarian reserve which is diagnosed by Bologna criterias
• abnormal semen analyse by WHO sperm criterias
• abnormal ovulation problems,tubal patency or uterine cavity

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

122 participants in 2 patient groups

fertile chip

Active Comparator group

Description:

sperm selection by using fertile chip and conventional methods

Treatment:

Device: fertile chip

classical ICSI procedure

No Intervention group

Description:

unexplained infertile couples who will be undertaken intracytoplasmic sperm injection (ICSI) for fertilisation