Status:
COMPLETED
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
Lead Sponsor:
Instituto de Investigación Sanitaria y Biomédica de Alicante
Conditions:
Infertility, Male
Eligibility:
All Genders
18-55 years
Phase:
NA
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 wit...
Detailed Description
Prospective pseudo-randomised study carried out in the reproduction unit of the Hospital General Universitario Dr. Balmis in Alicante. The study was divided into two phases, with both being conducted ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06524102
Start Date
January 1 2018
End Date
March 31 2022
Last Update
July 29 2024
Active Locations (1)
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1
ISABIAL
Alicante, Spain, 03010