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

Unexplained Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03355937
• Other study ID #: Ob&Gyn Fulya
• Status: Not yet recruiting
• Phase: N/A
• First received: November 15, 2017
• Last updated: November 22, 2017
• Start date: January 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: November 2017
• Source: Acibadem University
• Contact: Murat Dogan
• Phone: 00905056139577
• Email: muratdogan1984[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Recurrent Implantation Failure
• Unexplained Infertility

Intervention

Procedure:
• Sperm Chip
Sperm selection using by conventional or with sperm chip

Locations

Country	Name	City	State
Turkey	Acibadem Fulya Hospital	Istanbul	Besiktas

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Tasoglu S, Safaee H, Zhang X, Kingsley JL, Catalano PN, Gurkan UA, Nureddin A, Kayaalp E, Anchan RM, Maas RL, Tüzel E, Demirci U. Exhaustion of racing sperm in nature-mimicking microfluidic channels during sorting. Small. 2013 Oct 25;9(20):3374-84. doi: 1 — View Citation

Outcome

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