Magnetic Activated Cell Sorting in Artificial Insemination With Donor Sperm

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Other: MACS technique

• 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

Study Timeline

• Study Start: 2017-11-07
• Primary Completion: 2018-02-16
• Study Completion: 2018-04-13
• Study First Submitted: 2018-04-24
• Status Verified: 2018-09
• Study First Submitted QC: 2018-09-05
• Last Update Submitted: 2018-09-05
• Study First Posted: 2018-09-06
• Last Update Posted: 2018-09-06

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

Arm && Interventions

Group	Intervention	Description
MACS is applied to the sperm sample	MACS technique	Previous to the AID technique, the sperm sample undergoes capacitation through Percoll density gradient and MACS

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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
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 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

Trial Locations

Locations (1)

IVI Sevilla; 🇪🇸 Sevilla, Spain