The Aim of This Study is to Determine the Incidence of Alterations in Fluorescent In Situ Hybridi… (NCT06524102) | Clinical Trial Compass
CompletedNot Applicable
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
Spain10 participantsStarted 2018-01-01
Plain-language 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.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Euploid embryo rate
Timeframe: This variable was taken 2 days after obtaining the genetic result of the embryo biopsy.
Trial details
NCT IDNCT06524102
SponsorInstituto de Investigación Sanitaria y Biomédica de Alicante