Instituto Bernabeu
Alicante, 03016, Spain
NCT Number: NCT03153787
The objective of the present study to analyze the vaginal microbiome in patients who have not achieved gestation after oocyte donation treatment and after probiotic administration.
All patients will receive vaginal probiotic according to the standard regimen. Sample collection will be performed the embryo transfer day and on the day of the pregnancy test. Follow up of gestation will be carried out.
The analysis of the vaginal microbiome will be performed though massive genetic sequencing (determination of 16SRNA).
The study variables, among others, are vaginal microbiome pattern after probiotic administration, the gestation rate, and the abortion rate.
Looking for future studies?
Notify Me19 year–49 year
Female
Interventional
Not applicable
Alicante, 03016, Spain
This study will be performed after the observational study "Vaginal microbiome influence on the results of assisted reproduction techniques". The main goal of this previous study will be to identify patterns of vaginal and / or endometrial microbiome in relation to the gestation rate in women with implantation failure and / or repeat abortions who undergo an oocyte donation treatment. The vaginal and endometrial microbiome of women with (i) implantation failure, (ii) repeat abortions and (iii) control group without implantation failure or repeat abortions, will be analyzed before and after the embryo transfer.
Those women who do not achieve pregnancy will be eligible for the present study. The objective of the present study to analyze the vaginal microbiome in patients who have not achieved gestation after oocyte donation treatment and after probiotic administration.
All patients will receive vaginal probiotic according to the standard regimen: 1 tablet (via vaginal) for 5 days after menstruation during the same cycle of the next embryo transfer.
The vaginal sample will be analyzed after taking the probiotic. Sample collection will be performed the embryo transfer day and on the day of the pregnancy test. Follow up of gestation will be carried out.
Vaginal sample collection: obtention of vaginal fluid with vaginal swab by direct visualization. Direct visualization means having the patient in a lithotomy position, like a routine gynecological examination by visualization with a vaginal speculum.
The analysis of the vaginal microbiome will be performed though massive genetic sequencing (determination of 16SRNA). First of all, the extraction of RNA and subsequent analysis. We will analyze the groups of microorganisms, as well as the determination of patterns related to failure of implantation, repetitive abortions and gestation success.
The study variables, among others, are vaginal microbiome pattern after probiotic administration, the gestation rate, and the abortion rate. The vaginal microbiome will be compared with the results of the previous observational study.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Vaginal probiotic administration according to the standard regimen: 1 tablet (via vaginal) for 5 days after menstruation during the same cycle of the next embryo transfer.
Time frame: 2 weeks and 4 weeks
Vaginal microbiome will be analyzed through massive genetic sequencing (determination of 16S RRNA) Before and after probiotic administration
Time frame: 4 weeks
Gestation rate after assisted reproduction technique
Time frame: 45 weeks
Abortion rate (clinical and biochemical) after assisted reproduction technique
Time frame: 45 weeks
Live newborn rate after assisted reproduction technique
Time frame: 45 weeks
Complications during gestation after assisted reproduction technique
Instituto Bernabeu
Other
Influence of Vaginal and Endometrial Microbiome on the Results of Assisted Reproduction Techniques and Probiotic Administration Effect: Controlled Before-and-after Study
Acronym: RIFMicrobiome
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07462754
Implantation Failure
Wuhan, Hubei, China
View Trial DetailsNCT03843112
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Køge, Denmark
View Trial DetailsNCT01673399
Implantation Failure
Ghent, Oost-vlaanderen, Belgium
View Trial DetailsNCT07669623
Implantation Failure
Wuhan, Hubei, China
View Trial Details