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Completed

NCT Number: NCT03659812

Magnetic Activated Cell Sorting in Artificial Insemination With Donor Sperm

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

IVI Sevilla

Seville, 41011, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Pregnancy rate

    Time frame: 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.

  2. Implantation rate

    Time frame: 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.

  3. Live birth rate

    Time frame: 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 outcomes

  1. Sperm cell concentration

    Time frame: 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

  2. Sperm cell motility

    Time frame: 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

  3. Sperm cell morphology

    Time frame: 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

  4. Sperm cells vitality

    Time frame: 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

  5. Sperm sample volume

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

    The volume of sperm obtained after masturbation

Sponsors and collaborators

Lead sponsor

Vida Recoletas Sevilla

Other

Registry information

Official study title

Application of Magnetic Activated Cell Sorting (MACS) of Spermatozoa in Artificial Insemination Cycles With Donor Sperm (AID)

Acronym: MACSIAD

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 6, 2018
Registry last updated
Sep 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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