Magnetic Activated Cell Sorting in Artificial Insemination With Donor Sperm

Study Overview
=================
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.

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

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Other: MACS technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who undergo artificial insemination with donor sperm Signing an informed consent form to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MACS is applied to the sperm sample<br>Previous to the AID technique, the sperm sample undergoes capacitation through Percoll density gradient and MACS | Other: MACS technique<br>* 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.<br>|
| No Intervention: MACS is not applied to the sperm sample<br>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). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Magnetic activated cell sorting (MACS), Artificial insemination with donor sperm (AID), Spermatozoa, Sperm