Cytokines, vaginal microbiome and subfertility, a pilotstudy

Cytokines, vaginal microbiome and subfertility, a pilotstudy - cytokines and subfertility

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42405

Enrollment

100

Registered

2016-02-16

Start date

2017-07-28

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

idiopathic subfertility

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Women who would like to become pregnant; age up to 38 years; regular spontaneous cycles of 28 +/- 4 days; no abdominal surgery in history; serum chlamydia IgG negative; BMI * 30; good oral hygiëne

Exclusion criteria

Exclusion criteria: Chronic intestinal disease; salpingitis/appendicitis in history; fever in the preceding 2 weeks before entering the study; use of antibiotics in the 6 weeks preceding entry of study; low ovarian reserve (FSH > 10 IU/L menstrual cycle day 3, AMH

Design outcomes

Primary

Measure	Time frame
It is a pilot study. The primary aim of the study is to see whether there are differences between 5 cytokines and the profile of the vaginal microbiome between the two groups. This will allow to design a next study with sufficient and seize of the patient groups. Five cytokines have been selected, two will be assessed directly in the blood plasma (sTNFR1, IL 6) and three will be assessed after LPS challenging and 24 hour whole blood culture (TNF, IL 10 en IL 12). Vaginal microbioom. With the so called ISpro technic in which the spacer area between 23S and 16S gene will be amplified. Extended bacterial profiles will be made without sequencing. It has been shown that based on three different bacterial groups, the quantitative differences and the ratio between these groups, women who concievede after IVF could be distinguished from women whh did not conceive. This study will be used to confirm these findings.	—

Measure

Time frame

It is a pilot study. The primary aim of the study is to see whether there are differences between 5 cytokines and the profile of the vaginal microbiome between the two groups. This will allow to design a next study with sufficient and seize of the patient groups. Five cytokines have been selected, two will be assessed directly in the blood plasma (sTNF*R1, IL 6) and three will be assessed after LPS challenging and 24 hour whole blood culture (TNF*, IL 10 en IL 12). Vaginal microbioom. With the so called ISpro technic in which the spacer area between 23S and 16S gene will be amplified. Extended bacterial profiles will be made without sequencing. It has been shown that based on three different bacterial groups, the quantitative differences and the ratio between these groups, women who concievede after IVF could be distinguished from women whh did not conceive. This study will be used to confirm these findings.

—

Secondary

Measure	Time frame
Confirmation of previous results that a well define vaginale microbiome is not compatible with pregnancy	—

Countries

Netherlands

Outcome results