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Magnetic Activated Cell Sorting in Artificial Insemination With Donor Sperm

Not Applicable
Completed
Conditions
Infertility
Registration Number
NCT03659812
Lead Sponsor
IVI Sevilla
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
130
Inclusion Criteria
  • Women who undergo artificial insemination with donor sperm
  • Signing an informed consent form to participate in the study
Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Pregnancy rateUltrasound 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 rateThe 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 rateLive 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 Outcome Measures
NameTimeMethod
Sperm cell concentrationThis 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 cell motilityThis 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 morphologyThis 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

Sperm cells vitalityThis 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 sample volumeThis parameter is assessed when preparing the sample for artificial insemination (one hour before artificial insemination).

The volume of sperm obtained after masturbation

Trial Locations

Locations (1)

IVI Sevilla

🇪🇸

Sevilla, Spain

IVI Sevilla
🇪🇸Sevilla, Spain

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