Infertility Clinical Trial
— MACSIADOfficial title:
Application of Magnetic Activated Cell Sorting (MACS) of Spermatozoa in Artificial Insemination Cycles With Donor Sperm (AID)
Verified date | September 2018 |
Source | IVI Sevilla |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 130 |
Est. completion date | April 13, 2018 |
Est. primary completion date | February 16, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - Women who undergo artificial insemination with donor sperm - Signing an informed consent form to participate in the study |
Country | Name | City | State |
---|---|---|---|
Spain | IVI Sevilla | Sevilla |
Lead Sponsor | Collaborator |
---|---|
IVI Sevilla |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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. | |
Primary | 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 | 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). | |
Secondary | 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). | |
Secondary | 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). | |
Secondary | 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). | |
Secondary | 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). |
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