Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06524102
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-21
Brief Title:
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
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Efficacy of Annexin Columns MACS in Patients With Altered Sperm FISH Undergoing Assisted Reproductive Techniques
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 in parallel The research was approved by the Ethics Committee for Research on Medicines CEIm of the Alicante Department of Health The treatment and use of the clinical data required for this study complied with current legislation preserving the anonymity of the patients
Phase I A total of 250 sperm FISH tests were requested for different indications in men aged 18-55 years with normal karyotype Of the total number of tests requested 16 could not be performed due to low sperm count Finally 234 samples were analysed of which 20 had altered sperm FISH
Phase II From the previous phase not all patients with an altered FISH test were included in the second phase of the study some of them were lost for different reasons n10 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
To evaluate the efficacy of MACS on laboratory outcome fertilization rates abnormal fertilization biopsiable embryos and euploid embryos were compared between the study and control group
Phase I A total of 250 sperm FISH tests were requested for different indications in men aged 18-55 years with normal karyotype Of the total number of tests requested 16 could not be performed due to low sperm count Finally 234 samples were analysed of which 20 had altered sperm FISH
Phase II From the previous phase not all patients with an altered FISH test were included in the second phase of the study some of them were lost for different reasons n10 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
To evaluate the efficacy of MACS on laboratory outcome fertilization rates abnormal fertilization biopsiable embryos and euploid embryos were compared between the study and control group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None