Fertility DisordersNCT04641390
Interaction Between the Vaginal and Seminal Microbiome in Patients With an Altered Vaginal Microbiome Pattern Resistant to Treatment
An observational study of Fertility Disorders, run by Instituto Bernabeu at 1 site in Spain.
Trial summary
It,s a retrospective case-control pilot study is to be carried out. Twenty patients will be included in the study for each branch (a total of 60). The study population will be patients whose partners have a diagnosis of an altered vaginal microbiome with (Cases, n = 20) or without (Controls, n = 20) persistence to… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Fertility Disorders
- What is being tested?
- Analysis of the seminal microbiome of the partners of women with altered vaginal microbiome resistant to drug treatment and Analysis of the seminal microbiome of the partners of women with altered vaginal microbiome not resistant to drug treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2021to 15 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: The study population will be patients whose partners have a diagnosis of an altered vaginal microbiome with persistence of drug treatment or without persistence of drug treatment.
Who may be able to join
- Woman who has an altered vaginal microbiome when the presence of bacteria of the Lactobacillus genus is less than 90% and / or the presence of bacteria that cause bacterial vaginosis (Pj: Gardnerella) or that make embryo implantation difficult in a percentage is determined greater than 5%
- Males will be between 18 and 50 years old
- Signed informed consent accepting their participation in the study.
- Male donors will be between 18 and 35 years old
Who cannot join
- Men who present with fever
- Men who are under treatment with antibiotics
- Men who have an active sexually transmitted disease
- Men who have a chronic prostatitis or a urinary infection (such as epididymitis or orchitis).
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
University Miguel Hernández
Sant Joan d'Alacant, Alicante, 03550
RAUF N Nouni, DR, 677029706, raufrng@gmail.com
About this study
It,s a retrospective case-control pilot study is to be carried out. Twenty patients will be included in the study for each branch (a total of 60). The study population will be patients whose partners have a diagnosis of an altered vaginal microbiome with (Cases, n = 20) or without (Controls, n = 20) persistence to drug treatment. Since a normal reference seminal microbiome has not been described, we will include a control group that will consist of sperm donors (n = 20) who are considered fertile potential without reproductive problems.
The main objective of the project is to identify the interaction of the vaginal and seminal microbiome patterns in couples in which the vaginal pattern is altered and is persistent to drug treatment.
- Conditions
- Fertility Disorders
- Being tested
- Analysis of the seminal microbiome of the partners of women with altered vaginal microbiome resistant to drug treatment, Analysis of the seminal microbiome of the partners of women with altered vaginal microbiome not resistant to drug treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of the seminal microbiome of the partners of women with altered vaginal microbiome resistant to drug treatmentOther
The analysis of the seminal microbiome will be carried out by massive genetic sequencing
Analysis of the seminal microbiome of the partners of women with altered vaginal microbiome not resistant to drug treatmentOther
The analysis of the seminal microbiome will be carried out by massive genetic sequencing
| Study group | Role | What they receive |
|---|---|---|
| Casos | altered vaginal microbiome resistant to drug treatment Receives: Other: Analysis of the seminal microbiome of the partners of women with altered vaginal microbiome resistant to drug treatment | |
| Controles | Altered vaginal microbiome not resistant to drug treatment Receives: Other: Analysis of the seminal microbiome of the partners of women with altered vaginal microbiome not resistant to drug treatment | |
| semen donors | The semen donors included in the present work will be men between 18 and 35 years old who are included in the donation program of Instituto Bernabeu after having passed a series of physical, psychological, analytical, genetic and serological evaluations and are considered suitable for donation as established by Royal Decree-Law 9/2014. Likewise, donors are subjected to a series of seminal quality evaluations and seminal freeze-thaw tests in order to guarantee their fertile potential. In this way, the donors who are part of the Instituto Bernabeu donation program also comply with current legal regulations with a strict evaluation to be considered the gold standard of potentially fertile semen. In addition, it will be necessary for them to provide a signed informed consent accepting their participation in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants with alteration of the vaginal microbiome resistant to drug treatment
Measured: 16 months
Secondary outcomes (3)
Characteristics of the seminal microbiome of the participants whose partners with altered vaginal pattern responded well to drug treatment.
Measured: 16 months
Characteristics of the seminal microbiome pattern in patients whose partners have been diagnosed with an altered vaginal microbiome resistant to drug treatment.
Measured: 16 months
Semen donor participants eligible for donation as established by Royal Decree-Law 9/2014 to establish a seminal microbiome pattern considered optimal to compare it with participants with an altered seminal microbioma pattern.
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start1 Feb 2021
- Primary completion15 Dec 2021 (estimated)
- Study completion15 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Bernabeu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Belen Lledo, Instituto Bernabeu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04641390
- Sponsor's protocol ID
- InstitutoBernabeu2
- Status last verified
- Aug 2021
- First submitted
- 14 Nov 2020
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interaction Between the Vaginal and Seminal Microbiome in Patients With an Altered Vaginal Microbiome Pattern Resistant to Treatment
- ClinicalTrials.gov ID
- NCT04641390
- Acronym / sponsor ID
- InstitutoBernabeu2
- Conditions
- Fertility Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Instituto BernabeuUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 15 Dec 2021 (estimated)
- Study completion
- 15 Apr 2022 (estimated)
- First posted
- 23 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It,s a retrospective case-control pilot study is to be carried out. Twenty patients will be included in the study for each branch (a total of 60). The study population will be patients whose partners have a diagnosis of an altered vaginal microbiome with (Cases, n = 20) or without (Controls, n = 20) persistence to drug treatment. Since a normal reference seminal microbiome has not been described, we will include a control group that will consist of sperm donors (n = 20) who are considered fertile potential without reproductive problems.
The main objective of the project is to identify the interaction of the vaginal and seminal microbiome patterns in couples in which the vaginal pattern is altered and is persistent to drug treatment.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Casos | – | Other: Analysis of the seminal microbiome of the partners of women with altered vaginal microbiome resistant to drug treatmentaltered vaginal microbiome resistant to drug treatment |
| Controles | – | Other: Analysis of the seminal microbiome of the partners of women with altered vaginal microbiome not resistant to drug treatmentAltered vaginal microbiome not resistant to drug treatment |
| semen donors | – | –The semen donors included in the present work will be men between 18 and 35 years old who are included in the donation program of Instituto Bernabeu after having passed a series of physical, psychological, analytical, genetic and serological evaluations and are considered suitable for donation as established by Royal Decree-Law 9/2014. Likewise, donors are subjected to a series of seminal quality evaluations and seminal freeze-thaw tests in order to guarantee their fertile potential. In this way, the donors who are part of the Instituto Bernabeu donation program also comply with current legal regulations with a strict evaluation to be considered the gold standard of potentially fertile semen. In addition, it will be necessary for them to provide a signed informed consent accepting their participation in the study. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population will be patients whose partners have a diagnosis of an altered vaginal microbiome with persistence of drug treatment or without persistence of drug treatment.
Key inclusion criteria (4 listed)
- Woman who has an altered vaginal microbiome when the presence of bacteria of the Lactobacillus genus is less than 90% and / or the presence of bacteria that cause bacterial vaginosis (Pj: Gardnerella) or that make embryo implantation difficult in a percentage is determined greater than 5%
- Males will be between 18 and 50 years old
- Signed informed consent accepting their participation in the study.
- Male donors will be between 18 and 35 years old
Key exclusion criteria (4 listed)
- Men who present with fever
- Men who are under treatment with antibiotics
- Men who have an active sexually transmitted disease
- Men who have a chronic prostatitis or a urinary infection (such as epididymitis or orchitis).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analysis of the seminal microbiome of the partners of women with altered vaginal microbiome resistant to drug treatmentThe analysis of the seminal microbiome will be carried out by massive genetic sequencing | Other | Casos |
| Analysis of the seminal microbiome of the partners of women with altered vaginal microbiome not resistant to drug treatmentThe analysis of the seminal microbiome will be carried out by massive genetic sequencing | Other | Controles |
Primary outcome
Participants with alteration of the vaginal microbiome resistant to drug treatment
Time frame: 16 months
3 secondary outcomes
Characteristics of the seminal microbiome of the participants whose partners with altered vaginal pattern responded well to drug treatment.
Time frame: 16 months
Characteristics of the seminal microbiome pattern in patients whose partners have been diagnosed with an altered vaginal microbiome resistant to drug treatment.
Time frame: 16 months
Semen donor participants eligible for donation as established by Royal Decree-Law 9/2014 to establish a seminal microbiome pattern considered optimal to compare it with participants with an altered seminal microbioma pattern.
Time frame: 16 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
Related trials for Fertility Disorders
Active, not recruiting
Ovarian Tissue Cryopreservation in Children
Cancer
Not yet recruiting
Sperm, Exposure and Endocrine Disruptors
Fertility, Male Fertility
Recruiting
Dietary Intervention to Improve Fertility in Women With Endometriosis Undergoing IVF
Endometriosis
RecruitingObservational study
Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction, Premature Ovarian Insufficiency and Clinically Indicated Gonadectomy
Turner Syndrome, Post-menarcheal Adolescents
Active, not recruitingObservational study
Factors Influencing Fertility or Pregnancy Health
Menstrual Cycles, Conception
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fertility Disorders, run by Instituto Bernabeu at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact RAUF NOUNI, DR (677029706, raufrng@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants with alteration of the vaginal microbiome resistant to drug treatment (time frame: 16 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2021.