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

Primary Purpose

Infertility

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

MACS technique

About this trial

This is an interventional other trial for Infertility focused on measuring Magnetic activated cell sorting (MACS), Artificial insemination with donor sperm (AID), Spermatozoa, Sperm

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

IVI Sevilla

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MACS is applied to the sperm sample

MACS is not applied to the sperm sample

Arm Description

Previous to the AID technique, the sperm sample undergoes capacitation through Percoll density gradient and MACS

Previous to the AID technique, MACS only undergoes capacitation through Percoll density gradient, but not MACS technique

Outcomes

Primary Outcome Measures

Pregnancy rate

The number of pregnancies confirmed by ultrasound divided by the number of artificial insemination cycles. Pregnancy is confirmed by ultrasound examination.

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.

Live birth rate

The number of live births divided by the number of artificial insemination cycles

Secondary Outcome Measures

Sperm cell concentration

Concentration of sperm cells in sperm sample before and after applying the MACS technique

Sperm cell motility

Proportion of sperm cells with progressive motility (according to World Health Organisation 2010 criteria) before and after applying the MACS technique

Sperm cell morphology

Proportion of sperm cells with normal morphology (according to World Health Organisation 2010 criteria) before and after applying the MACS technique

Sperm cells vitality

Proportion of live sperm cells before and after applying the MACS technique

Sperm sample volume

The volume of sperm obtained after masturbation

Full Information

NCT ID

NCT03659812

First Posted

April 24, 2018

Last Updated

September 5, 2018

Sponsor

IVI Sevilla

1. Study Identification

Unique Protocol Identification Number

NCT03659812

Brief Title

Magnetic Activated Cell Sorting in Artificial Insemination With Donor Sperm

Acronym

MACSIAD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

November 7, 2017 (Actual)

Primary Completion Date

February 16, 2018 (Actual)

Study Completion Date

April 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

IVI Sevilla

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility

Keywords

Magnetic activated cell sorting (MACS), Artificial insemination with donor sperm (AID), Spermatozoa, Sperm

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

130 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MACS is applied to the sperm sample

Arm Type

Experimental

Arm Description

Previous to the AID technique, the sperm sample undergoes capacitation through Percoll density gradient and MACS

Arm Title

MACS is not applied to the sperm sample

Arm Type

No Intervention

Arm Description

Previous to the AID technique, MACS only undergoes capacitation through Percoll density gradient, but not MACS technique

Intervention Type

Other

Intervention Name(s)

MACS technique

Intervention Description

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.

Primary Outcome Measure Information:

Title

Pregnancy rate

Description

The number of pregnancies confirmed by ultrasound divided by the number of artificial insemination cycles. Pregnancy is confirmed by ultrasound examination.

Time Frame

Ultrasound examination is performed 5 weeks after artificial insemination. Pregnancy rate is calculated during the phase of data analysis.

Title

Implantation rate

Description

Time Frame

The beta hCG analysis is performed 15 days after artificial insemination. Implantation rate is calculated during the phase of data analysis.

Title

Live birth rate

Description

The number of live births divided by the number of artificial insemination cycles

Time Frame

Live births are assessed at delivery (end of pregnancy period). Live birth rate is calculated during the phase of data analysis

Secondary Outcome Measure Information:

Title

Sperm cell concentration

Description

Concentration of sperm cells in sperm sample before and after applying the MACS technique

Time Frame