The Aim of This Study is to Determine the Incidence of Alterations in Fluorescent In Situ Hybridisation (FISH) of Spermatozoa and to Evaluate the Efficacy of the Use of Annexin Columns (MACS®) in Patients With Altered FISH Undergoing In Vitro Fertilisation Techniques

NCT06524102 | Completed

• 1 other identifier: 190767
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

250 petitions for FISH of spermatozoa were requested, determining the total and particular incidence in each of the indications collected. The effect of annexin columns was evaluated in 10 couples with altered FISH. In each of the couples, oocytes were pseudo-randomised to the control group and MACS®. All couples received experimental treatment. Mixed logistic regression model were adjusted to evaluate the effect of MACS® on the response variables studied.

Conditions

Infertility, Male

Keywords

In Vitro Fertilization; sperm FISH; annexin columns; MACS; Preimplantation Genetic Testing for aneuploidies

Outcome Measures

Primary Outcomes (1)

• Euploid embryo rate

  Embryos without chromosomal alterations in relation to the total number of those that were informative.

  This variable was taken 2 days after obtaining the genetic result of the embryo biopsy.

Secondary Outcomes (2)

• Fertilization rate

  This variable was taken 17-20 hours after oocyte insemination.

• Biopsiable embryo rate

  This variable was taken on the 3rd day of embryonic development, at the time of the embryo biopsy. .

Study Arms (2)

MACS

EXPERIMENTAL

Oocytes corresponding to this group were inseminated by spermatozoa selected after the use of MACS.

Device: Magnetic Activated Cell Sorting

Control

NO INTERVENTION

Oocytes corresponding to this group were inseminated with spermatozoa obtained after density gradient centrifugation.

Interventions

Magnetic Activated Cell Sorting DEVICE

The MACS® ART Annexin V System has been designed for the in vitro elimination of apoptotic human spermatozoa in fresh, cryopreserved or otherwise manipulated semen samples. Samples processed by this technique can be subsequently used in any assisted reproduction procedure. Annexin V recognizes externalized phosphatidylserine (ePS) on the plasma membrane of apoptotic spermatozoa. Depletion of the altered sperm begins with magnetic tagging of the sperm. The system selectively retains unwanted sperm by utilizing the natural ability of annexin V to recognize the ePS on the plasma membrane of the altered sperm, because annexin V is conjugated to metal microspheres. The labeled cells pass through a separation column in a fixed magnetic field. Unwanted (altered) spermatozoa are selectively retained in the separation column. Unlabeled spermatozoa pass through the column where they are collected for later use.

Also known as: MACS

MACS

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women between 18 and 40 years of age. Men between 18 and 55 years of age.
• Couples without any common, previous and healthy children.
• Couples with indication of IVF-ICSI cycle with Preimplantation Genetic Test for Aneuploidy (PGT-A).
• Men with altered sperm FISH results.

You may not qualify if:

• Prior voluntary sterilization.
• Existence of documented medical contraindication for infertility treatment.
• Existence of documented medical contraindication to pregnancy.
• Existence of a documented medical situation that seriously interferes with the development of the offspring.
• Impossibility to comply with the treatment for health-related reasons or other family or social environment-related reasons.
• Existence of a documented situation referring to any other circumstance that may seriously interfere with the development of the offspring submitted for consideration to a health care ethics committee or similar body.
• One or both partners with positive serology for HIV, HBV and VDRL.
• One or both partners with partner with altered karyotype.

Sponsors & Collaborators

• Instituto de Investigación Sanitaria y Biomédica de Alicante: lead

Study Sites (1)

ISABIAL

Alicante, 03010, Spain

Location

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Access to the data was restricted to the study investigators, health authorities and ISABIAL advisory bodies, when necessary, to check the study data and procedures, but always maintaining confidentiality. The data collected for the study was identified by a code, so that no information that could identify the participants was included, and only the researchers were able to link the anonymized data to the clinical history.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Biologist

Model Details: A total of 10 couples with no previous children in common, negative serology and normal karyotype were included. Females were aged less than 40 years and males less than 50 years at the time of treatment. The semen sample of each couple was capacitated by density gradient centrifugation (DGC) and swim up, forming the control group. An aliquot was taken that was destined to pass through the annexin columns (MACS® ART, Miltenyl Biotic GmbH, Germany) constituting the study group. The oocytes obtained in each of the couples were pseudo-randomized and inseminated by ICSI with sperm from the study group and the control group. All couples benefited from the experimental treatment since they had the opportunity to inseminate their oocytes with sperm from both groups, thus excluding treatment bias or asymmetry.

Study Record Dates

• First Submitted: July 21, 2024
• First Posted: July 29, 2024
• Study Start: January 1, 2018
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)