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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Casos | altered vaginal microbiome resistant to drug treatment |
| |
| Controles | Altered vaginal microbiome not resistant to drug treatment |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Analysis of the seminal microbiome of the partners of women with altered vaginal microbiome resistant to drug treatment | Other | The analysis of the seminal microbiome will be carried out by massive genetic sequencing |
| Measure | Description | Time Frame |
|---|---|---|
| Participants with alteration of the vaginal microbiome resistant to drug treatment | 16 months |
| Measure | Description | Time Frame |
|---|---|---|
| Characteristics of the seminal microbiome of the participants whose partners with altered vaginal pattern responded well to drug treatment. | 16 months | |
| Characteristics of the seminal microbiome pattern in patients whose partners have been diagnosed with an altered vaginal microbiome resistant to drug treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| RAUF NOUNI, DR | Contact | 677029706 | raufrng@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Miguel Hernández | Recruiting | Sant Joan d'Alacant | Alicante | 03550 | Spain |
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| Analysis of the seminal microbiome of the partners of women with altered vaginal microbiome not resistant to drug treatment | Other | The analysis of the seminal microbiome will be carried out by massive genetic sequencing |
|
| 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. | 16 months |