Magnetic Activated Cell Sorting in Artificial Insemination With Donor Sperm

Infertility Clinical Trial

— MACSIAD  

Official title:

Application of Magnetic Activated Cell Sorting (MACS) of Spermatozoa in Artificial Insemination Cycles With Donor Sperm (AID)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03659812
• Other study ID #: IVISEV-006-IAD
• Status: Completed
• Phase: N/A
• Start date: November 7, 2017
• Est. completion date: April 13, 2018

Study information

• Verified date: September 2018
• Source: IVI Sevilla
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to analyse the efficacy of MACS technique for the selection of spermatozoa and its effects on implantation, pregnancy and miscarriage rate. This study will be performed by two IVI clinics (IVI Sevilla and IVI Madrid) with the purpose of finding new techniques that allow us to better select spermatozoa and improve the results of assisted reproduction techniques.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: April 13, 2018
• Est. primary completion date: February 16, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Women who undergo artificial insemination with donor sperm

• Signing an informed consent form to participate in the study

Related Conditions & MeSH terms

• Infertility

Intervention

Other:
• MACS technique
MACS is a technique that allow us to tag and detect apoptotic spermatozoa. These apoptotic spermatozoa have phosphatidylserine in their membranes, so we add magnetic beads with Annexin V, which binds specifically to phosphatidylserine. The spermatozoa are then tagged and can be retained in a magnetic field, allowing us to collect just the non-apoptotic spermatozoa.

Locations

Country	Name	City	State
Spain	IVI Sevilla	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
IVI Sevilla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy rate	The number of pregnancies confirmed by ultrasound divided by the number of artificial insemination cycles. Pregnancy is confirmed by ultrasound examination.	Ultrasound examination is performed 5 weeks after artificial insemination. Pregnancy rate is calculated during the phase of data analysis.
Primary	Implantation rate	The number of positive results of beta human chorionic gonadotropin (hCG) test divided by the number of artificial insemination cycles. Implantation is confirmed through the analysis of beta hCG in blood.	The beta hCG analysis is performed 15 days after artificial insemination. Implantation rate is calculated during the phase of data analysis.
Primary	Live birth rate	The number of live births divided by the number of artificial insemination cycles	Live births are assessed at delivery (end of pregnancy period). Live birth rate is calculated during the phase of data analysis
Secondary	Sperm cell concentration	Concentration of sperm cells in sperm sample before and after applying the MACS technique	This parameter is assessed when preparing the sample for artificial insemination (one hour before artificial insemination).
Secondary	Sperm cell motility	Proportion of sperm cells with progressive motility (according to World Health Organisation 2010 criteria) before and after applying the MACS technique	This parameter is assessed when preparing the sample for artificial insemination (one hour before artificial insemination).
Secondary	Sperm cell morphology	Proportion of sperm cells with normal morphology (according to World Health Organisation 2010 criteria) before and after applying the MACS technique	This parameter is assessed when preparing the sample for artificial insemination (one hour before artificial insemination).
Secondary	Sperm cells vitality	Proportion of live sperm cells before and after applying the MACS technique	This parameter is assessed when preparing the sample for artificial insemination (one hour before artificial insemination).
Secondary	Sperm sample volume	The volume of sperm obtained after masturbation	This parameter is assessed when preparing the sample for artificial insemination (one hour before artificial insemination).