To answer the question if dried blood spot (DBS) analysis and saliva hormone testing are reliable methods to determine the concentration of NGF-ß in healthy subjects.
ID
Source
Brief title
Condition
- Other condition
- Gonadotrophin and sex hormone changes
Synonym
Health condition
valideren van diagnostische testen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are the correlation and limits of agreement between
dried blood spots/saliva samples compared to venous blood concentration.
Secondary outcome
not applicable
Background summary
There are roughly two types of ovulation: spontaneous and induced. Copulation
is the speculated mechanism behind induced ovulation. The ovulation induction
substance in semen has been identified as nerve growth factor * (NGF-*). In
animal studies, semen plasma derived NGF-* indeed has an effect on female
ovulation, follicle development and a luteotropic effect. The role of NGF-* on
human ovulation has never been studied. It is known that NGF-* plays an
important role in many different types of human tissue, for instance the
nervous system and immune system. All studies use venous blood to measure the
NGF-* concentration. However, in order to study the effect of NGF-* on human
ovulation, multiple serial measurements are needed, ideally immediately before
and after natural intercourse. Therefore, a patient-friendly and minimally
interrupting method is necessary. Serial dried blood spot analysis and saliva
sample testing are potential methods, but both are not validated for NGF-* yet.
The aim of this study will be to do a method comparison study, to validate the
use of both methods compared to venous blood for NGF-*.
Study objective
To answer the question if dried blood spot (DBS) analysis and saliva hormone
testing are reliable methods to determine the concentration of NGF-ß in healthy
subjects.
Study design
Cross sectional method comparison validation study.
Study burden and risks
The procedure for participants includes one hospital visit or home visit for
saliva, dried blood spot and venous blood sampling and a questionnaire has to
be completed. There will be no extra risks nor benefits for the participants.
The risk analysis for this study concluded the risk for (serious) adverse
events is negligible.
De Boelelaan 1118
Amsterdam 1081 HZ
NL
De Boelelaan 1118
Amsterdam 1081 HZ
NL
Listed location countries
Age
Inclusion criteria
Healthy female and male participants, 18 years or older, who are willing to give informed consent, have sufficient command of Dutch or English language and are capable of understanding participants information.
Exclusion criteria
- Contraindications for donating blood (phlebitis, dermatitis, psoriasis, lymphedema, arterial venous fistula, hematoma on or around insert place, mamma-amputation or axillary dissection of lymph nodes)
- Poor dental condition
- Age <18 years
- Volunteers who brushed their teeth within 45 minutes prior to saliva sample collection.
- Volunteers who had dental work within 24 hours prior to saliva sample collection.
- Volunteers who had their last meal, or drank anything except for water within 60 minutes prior to saliva sample collection.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL63048.029.17 |
| OMON | NL-OMON25927 |