The objective of the study is the falsification of the following null hypotheses:1. The pro-inflammatory status of the innate immune system of normal fertile women and the of women with idiopatic subfertility are not different.2. The profile of the…
ID
Source
Brief title
Condition
- Immune disorders NEC
- Reproductive tract disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
Confirmation of previous results that a well define vaginale microbiome is not
compatible with pregnancy
Background summary
Rationale:
Subfertility is commonly associated with a specific chronic inflammation
cytokine profile and with a specific profile of the vaginal microbiome. We
suggest that the association between these two variables and their association
with subfertility will give rise to new opportunities for the treatment of
subfertility.
The identification of these specific cytokine and vaginal microbiome profiles
may become an important tool in the decision making, whether embarking upon
expensive assisted reproductive treatments, due to a poor outcome, should be
contraindicated.
Study objective
The objective of the study is the falsification of the following null
hypotheses:
1. The pro-inflammatory status of the innate immune system of normal fertile
women and the of women with idiopatic subfertility are not different.
2. The profile of the vaginal microbiome of normal fertile women and the of
women with idiopathic subfertility are not different
3. There is no statistical association between the profile vaginale microbiome
en de pro-inflammatoire and the status vof the innate immume system
Study design
open, prospective, descriptive, comparative pilot study.
Study burden and risks
The burden is small. The study does not demand extra visits to the clinic,
Bloodsampling of two 15 cc tubes (on one occasion) and one vaginal swab will be
taken just prior to the IUI procedure.
The benefit for future subfertile women may be substantial. In case vaginal
microbiome- and cytokine profiling can identify profiles incompatible with
pregnancy then treatments as IVF/ICSI or IUI should not be undertaken. Aiming
at pregnancy compatible profiles, before embarking upon stressful and expensive
modes of subfertility treatments, may become a priority in subfertility care.
Heerenveenseweg 99b
Wolvega 8471ZA
NL
Heerenveenseweg 99b
Wolvega 8471ZA
NL
Listed location countries
Age
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
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 < 1ng/mL)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL54415.099.15 |