Magnetic Activated Cell Sorting in Artificial Insemination With Donor Sperm

NCT03659812 | Completed

• 1 other identifier: IVISEV-006-IAD
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Keywords

Magnetic activated cell sorting (MACS); Artificial insemination with donor sperm (AID); Spermatozoa; Sperm

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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 Outcomes (5)

• Sperm cell concentration

  This parameter is assessed when preparing the sample for artificial insemination (one hour before artificial insemination).

• Sperm cell motility

  This parameter is assessed when preparing the sample for artificial insemination (one hour before artificial insemination).

• Sperm cell morphology

  This parameter is assessed when preparing the sample for artificial insemination (one hour before artificial insemination).

• Sperm cells vitality

  This parameter is assessed when preparing the sample for artificial insemination (one hour before artificial insemination).

• Sperm sample volume

  This parameter is assessed when preparing the sample for artificial insemination (one hour before artificial insemination).

Study Arms (2)

MACS is applied to the sperm sample

EXPERIMENTAL

Previous to the AID technique, the sperm sample undergoes capacitation through Percoll density gradient and MACS

Other: MACS technique

MACS is not applied to the sperm sample

NO INTERVENTION

Previous to the AID technique, MACS only undergoes capacitation through Percoll density gradient, but not MACS technique

Interventions

MACS technique OTHER

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.

MACS is applied to the sperm sample

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women who undergo artificial insemination with donor sperm
• Signing an informed consent form to participate in the study

Sponsors & Collaborators

• Vida Recoletas Sevilla: lead

Study Sites (1)

IVI Sevilla

Seville, 41011, Spain

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: September 6, 2018
• Study Start: November 7, 2017
• Primary Completion: February 16, 2018
• Study Completion: April 13, 2018
• Last Updated: September 6, 2018

Record last verified: 2018-09

Locations

ES (1)