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
Sponsored by
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
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
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
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
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.
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
This parameter is assessed when preparing the sample for artificial insemination (one hour before artificial insemination).
Title
Sperm cell motility
Description
Proportion of sperm cells with progressive motility (according to World Health Organisation 2010 criteria) before and after applying the MACS technique
Time Frame
This parameter is assessed when preparing the sample for artificial insemination (one hour before artificial insemination).
Title
Sperm cell morphology
Description
Proportion of sperm cells with normal morphology (according to World Health Organisation 2010 criteria) before and after applying the MACS technique
Time Frame
This parameter is assessed when preparing the sample for artificial insemination (one hour before artificial insemination).
Title
Sperm cells vitality
Description
Proportion of live sperm cells before and after applying the MACS technique
Time Frame
This parameter is assessed when preparing the sample for artificial insemination (one hour before artificial insemination).
Title
Sperm sample volume
Description
The volume of sperm obtained after masturbation
Time Frame
This parameter is assessed when preparing the sample for artificial insemination (one hour before artificial insemination).
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women who undergo artificial insemination with donor sperm
Signing an informed consent form to participate in the study
Facility Information:
Facility Name
IVI Sevilla
City
Sevilla
ZIP/Postal Code
41011
Country
Spain
12. IPD Sharing Statement
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Magnetic Activated Cell Sorting in Artificial Insemination With Donor Sperm
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