Magnetic Activated Cell Sorting in Artificial Insemination With Donor Sperm (MACSIAD)

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

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.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Other: MACS technique

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Sevilla, Spain, 41011
    • IVI Sevilla

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women who undergo artificial insemination with donor sperm
• Signing an informed consent form to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: MACS is applied to the sperm sample; Previous to the AID technique, the sperm sample undergoes capacitation through Percoll density gradient and MACS	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.
NO_INTERVENTION: MACS is not applied to the sperm sample; Previous to the AID technique, MACS only undergoes capacitation through Percoll density gradient, but not MACS technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).
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).
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).
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).
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).

Collaborators and Investigators

• Sponsor: IVI Sevilla

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 7, 2017
• Primary Completion (ACTUAL): February 16, 2018
• Study Completion (ACTUAL): April 13, 2018

Study Registration Dates

• First Submitted: April 24, 2018
• First Submitted That Met QC Criteria: September 5, 2018
• First Posted (ACTUAL): September 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 6, 2018
• Last Update Submitted That Met QC Criteria: September 5, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Sperm; Spermatozoa; Magnetic activated cell sorting (MACS); Artificial insemination with donor sperm (AID)
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: IVISEV-006-IAD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No