Ignite Creation Date:
2024-05-06 @ 3:18 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04585984
Status:
RECRUITING
Last Update Posted:
2024-03-05
First Post:
2020-10-06
Brief Title:
Effect of Antioxidant Probiotic Administration on Seminal Quality and Reproductive Outcomes
Sponsor:
Fundación IVI
Organization:
Fundación IVI
Study Overview
Official Title:
Effect of Antioxidant Probiotic Administration on Seminal Quality and Reproductive Outcomes
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The quality of semen plays a fundamental role in correct fertilization and development of normal embryos that result in a live birth Unfortunately semen quality has declined during the last decades and reduced more and more The cases of male factor infertility currently correspond to 30 of the reported cases of infertility The parameters that are directly affected in infertile men reflecting an impaired spermatogenesis are sperm concentration motility morphology ejaculate volume and DNA damage in addition to various alterations at the molecular level that often go unnoticed and are related to the physiological capacity of the sperm These alterations result in a decrease in reproductive capacity which leads to the need for assisted reproduction techniques ART The identification of new ways to increase the quality of sperm could be very useful to improve the reproductive performance of patients
Probiotics are defined as living microorganisms which when administered in adequate amounts confer benefits for the health of the host The consumption of probiotics is increasing worldwide as therapy for many different diseases and disorders In the field of assisted reproduction the microbiome has been extensively studied with respect to the female endometrium to assess endometrial receptivity However there is little evidence about the role of the microbiome in semen Previous studies demonstrated a moderate improvement on some sperm parameters but still there is a need to confirm its translation into a clinical contribution to reproductive success
The aim of this study is to evaluate the effect of these strains Lactobacillus rhamnosus CECT8361 and Bifidobacterium longum CECT7347 on the seminal quality of infertile patients coming to IVIRMA clinics to undergo their first IVFICSI cycle by means of determining direct improvement on the basic sperm analysis results on sperm DNA integrity and on the seminal microbiome profile to ultimately evaluate the effect that it may have on the embryo quality and reproductive results of the cycles of these patients
Probiotics are defined as living microorganisms which when administered in adequate amounts confer benefits for the health of the host The consumption of probiotics is increasing worldwide as therapy for many different diseases and disorders In the field of assisted reproduction the microbiome has been extensively studied with respect to the female endometrium to assess endometrial receptivity However there is little evidence about the role of the microbiome in semen Previous studies demonstrated a moderate improvement on some sperm parameters but still there is a need to confirm its translation into a clinical contribution to reproductive success
The aim of this study is to evaluate the effect of these strains Lactobacillus rhamnosus CECT8361 and Bifidobacterium longum CECT7347 on the seminal quality of infertile patients coming to IVIRMA clinics to undergo their first IVFICSI cycle by means of determining direct improvement on the basic sperm analysis results on sperm DNA integrity and on the seminal microbiome profile to ultimately evaluate the effect that it may have on the embryo quality and reproductive results of the cycles of these patients
Detailed Description:
This is a prospective randomized unicentric intervention study aimed at evaluating the effect of the combination of two probiotics on seminal quality and subsequent reproductive outcomes of infertile patients As it is a food supplement we will be subject to the Biomedicine Regulation and not to the Clinical Trials Regulation as already classified by the Spanish Drug Agency The study will be conducted on infertile patients at the IVIRMA Valencia clinic for two years to complete planned interventions and data collection and analysis The reference population includes infertile patients coming to the clinic for IVFICSI assisted reproduction treatment with own or donated oocytes
Patients will come to the clinic to undergo the treatment If their characteristics are in accord with the inclusion criteria the study will be presented and explained to them and their partners so they can evaluate their participation in it If they wish to participate they will sign an informed consent form and they will be randomized using a computer-generated randomisation list into the control group who will receive placebo or the treatment group who will receive the probiotic compound
The success rate in patients with these characteristics confirmed by the evaluation of historical information from the clinics own database is approximately 35 of the cycles using own oocytes which can be used as a valid approximation In a unilateral contrast test assuming a risk of an alpha error of 005 and a beta statistical power of 80 to demonstrate a difference of 15 thanks to the intervention we need a number of 134 cases per arm and assuming losses of 5 during the follow-up this number would be rounded to 140 cases per study group which makes a total of 280 couples to be included in the study
The trial is double-blind the patient the investigator and all site personnel with the exception of the trial nursecoordinator andor pharmacy assistant will remain blinded throughout the course of the trial as to which treatment each subject received including the assessing physician the embryologist and other auxiliary members of the team
The male assigned to the experimental group will start taking a 50 combination of the two probiotics Lactobacillus rhamnosus CECT8361 and Bifidobacterium longum CECT7347 at a dose of 109 CFUday on the same day of the first visit The probiotics will be supplied by the company ADM Biopolis SL Valencia Spain The carrier of lyophilized probiotics is maltodextrin and the mixture is encapsulated in hypromellose capsules The patient will take one capsule daily corresponding to the administration of 109 cfuday The patient should take these probiotics for at least 21 days before undergoing an assisted reproduction cycle Patients receiving the placebo will be following the same instructions For both groups of patients a seminal sample will be collected on their first visit to evaluate the baseline quality of the semen as well as a microbiome analysis will be carried out using 16S rRNA sequencing by ADM Biopolis to determine the status of the semen at the starting point of the study After 21 days the patients will be appointed to deposit a second semen sample in order to perform the IVFICSI cycle This sample will also be analysed both for semen parameters and microbiome Values obtained from both of the samples collected will be compared to observe the effect of the administration of the probiotic on the quality of sperm and its microbial population
Fresh semen samples will be evaluated by means of a spermiogram following the standard operating procedures in which data will be collected on volume pH sperm concentration sperm mobility cell viability and morphology In addition a DNA fragmentation analysis will be carried out using the Halosperm G2 kit Halotech based on the sperm chromatin dispersion technique A part of the fresh sample will be frozen by submersion into liquid nitrogen and then storage in a -80ºC freezer and sent to ADM Biopolis to perform the taxonomical identification of the bacterial populations in the semen samples using 16S rRNA sequencing with the Ion Torrent platform Lifetechnologies
Once the IVFICSI has been performed and oocytes have been correctly fertilised embryo selection and blastocyst transfer will be carried out according to the usual medical practice to the womans uterus so that they can continue their development in the womb
During recruitment the couple will also sign a consent form allowing the team to collect data from the results of the cycle both during embryo development and during the pregnancy and the delivery
A database will be defined with the variables destined to be analysed according to the objectives set semen quality analysis sperm DNA fragmentation microbial analysis embryo development gestation and delivery The exported data will be duly codified in order to protect the clinical and personal information of the patients according to the Spanish data protection law Finally and prior to the statistical study an exploratory data analysis will be carried out to review the quality of the information extracted
The main variable of the study is the live birth rate per cycle defined as the percentage of cases in which a complete treatment of assisted reproduction is carried out with control or experimental semen which manage to obtain offspring for each cycle of ovarian stimulation included in the study
Patients will come to the clinic to undergo the treatment If their characteristics are in accord with the inclusion criteria the study will be presented and explained to them and their partners so they can evaluate their participation in it If they wish to participate they will sign an informed consent form and they will be randomized using a computer-generated randomisation list into the control group who will receive placebo or the treatment group who will receive the probiotic compound
The success rate in patients with these characteristics confirmed by the evaluation of historical information from the clinics own database is approximately 35 of the cycles using own oocytes which can be used as a valid approximation In a unilateral contrast test assuming a risk of an alpha error of 005 and a beta statistical power of 80 to demonstrate a difference of 15 thanks to the intervention we need a number of 134 cases per arm and assuming losses of 5 during the follow-up this number would be rounded to 140 cases per study group which makes a total of 280 couples to be included in the study
The trial is double-blind the patient the investigator and all site personnel with the exception of the trial nursecoordinator andor pharmacy assistant will remain blinded throughout the course of the trial as to which treatment each subject received including the assessing physician the embryologist and other auxiliary members of the team
The male assigned to the experimental group will start taking a 50 combination of the two probiotics Lactobacillus rhamnosus CECT8361 and Bifidobacterium longum CECT7347 at a dose of 109 CFUday on the same day of the first visit The probiotics will be supplied by the company ADM Biopolis SL Valencia Spain The carrier of lyophilized probiotics is maltodextrin and the mixture is encapsulated in hypromellose capsules The patient will take one capsule daily corresponding to the administration of 109 cfuday The patient should take these probiotics for at least 21 days before undergoing an assisted reproduction cycle Patients receiving the placebo will be following the same instructions For both groups of patients a seminal sample will be collected on their first visit to evaluate the baseline quality of the semen as well as a microbiome analysis will be carried out using 16S rRNA sequencing by ADM Biopolis to determine the status of the semen at the starting point of the study After 21 days the patients will be appointed to deposit a second semen sample in order to perform the IVFICSI cycle This sample will also be analysed both for semen parameters and microbiome Values obtained from both of the samples collected will be compared to observe the effect of the administration of the probiotic on the quality of sperm and its microbial population
Fresh semen samples will be evaluated by means of a spermiogram following the standard operating procedures in which data will be collected on volume pH sperm concentration sperm mobility cell viability and morphology In addition a DNA fragmentation analysis will be carried out using the Halosperm G2 kit Halotech based on the sperm chromatin dispersion technique A part of the fresh sample will be frozen by submersion into liquid nitrogen and then storage in a -80ºC freezer and sent to ADM Biopolis to perform the taxonomical identification of the bacterial populations in the semen samples using 16S rRNA sequencing with the Ion Torrent platform Lifetechnologies
Once the IVFICSI has been performed and oocytes have been correctly fertilised embryo selection and blastocyst transfer will be carried out according to the usual medical practice to the womans uterus so that they can continue their development in the womb
During recruitment the couple will also sign a consent form allowing the team to collect data from the results of the cycle both during embryo development and during the pregnancy and the delivery
A database will be defined with the variables destined to be analysed according to the objectives set semen quality analysis sperm DNA fragmentation microbial analysis embryo development gestation and delivery The exported data will be duly codified in order to protect the clinical and personal information of the patients according to the Spanish data protection law Finally and prior to the statistical study an exploratory data analysis will be carried out to review the quality of the information extracted
The main variable of the study is the live birth rate per cycle defined as the percentage of cases in which a complete treatment of assisted reproduction is carried out with control or experimental semen which manage to obtain offspring for each cycle of ovarian stimulation included in the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None