Infertility
Conditions
Keywords
Magnetic activated cell sorting (MACS), Artificial insemination with donor sperm (AID), Spermatozoa, Sperm
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.
Interventions
OTHERMACS 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.
Sponsors
Vida Recoletas Sevilla
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Women who undergo artificial insemination with donor sperm * Signing an informed consent form to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy rate | Ultrasound examination is performed 5 weeks after artificial insemination. Pregnancy rate is calculated during the phase of data analysis. | The number of pregnancies confirmed by ultrasound divided by the number of artificial insemination cycles. Pregnancy is confirmed by ultrasound examination. |
| Implantation rate | The beta hCG analysis is performed 15 days after artificial insemination. Implantation rate is calculated during the phase of data analysis. | 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 | Live births are assessed at delivery (end of pregnancy period). Live birth rate is calculated during the phase of data analysis | The number of live births divided by the number of artificial insemination cycles |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sperm cells vitality | This parameter is assessed when preparing the sample for artificial insemination (one hour before artificial insemination). | Proportion of live sperm cells before and after applying the MACS technique |
| Sperm cell concentration | This parameter is assessed when preparing the sample for artificial insemination (one hour before artificial insemination). | Concentration of sperm cells in sperm sample before and after applying the MACS technique |
| Sperm sample volume | This parameter is assessed when preparing the sample for artificial insemination (one hour before artificial insemination). | The volume of sperm obtained after masturbation |
| Sperm cell motility | This parameter is assessed when preparing the sample for artificial insemination (one hour before artificial insemination). | Proportion of sperm cells with progressive motility (according to World Health Organisation 2010 criteria) before and after applying the MACS technique |
| Sperm cell morphology | This parameter is assessed when preparing the sample for artificial insemination (one hour before artificial insemination). | Proportion of sperm cells with normal morphology (according to World Health Organisation 2010 criteria) before and after applying the MACS technique |
Countries
Spain
Outcome results
None listed