Our primary objective is to assess whether maternal nutrition is reflected in serum and follicular fluid composition, and whether this affects IVF outcome.Our secondary objectives are a) to assess whether nutrition related follicular fluid…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
subfertiliteit
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The level of lipid and carbohydrate metabolism related products in follicular
fluid
Secondary outcome
- The level of metabolism related products in serum
- IVF outcomes such as oocyte quality, fertilization, embryo development,
pregnancy and live birth and perinatal outcomes such as gestational age, birth
weight and congenital malformations.
- Nutrition of the woman in the 4 days preceding the ovum pick up
- Results of gene expression analysis of granulose cells
Background summary
Annually, 17,000 IVF treatments are performed in the Netherlands, with an
average success rate of *only* 21%. Efforts are done to increase this rate in
order to give more patients the possibility of raising a family. The rate of
success in terms of pregnancy is determined, among other factors, by the
quality of the oocytes retrieved from women by an ovarian follicle punction.
One of the most important factors that affects oocyte quality, besides age, is
the microenvironment of the oocyte inside the ovary, that is created by the
follicular fluid and the cumulus, granulosa and theca cells that surround the
follicle. An altered follicular fluid composition alters the microenvironment
of the oocyte and might play a role in deprived oocyte development and
subsequent failure of the IVF treatment.
With adverse lifestyle and overnutrition as an emerging problem in our society
in relation to healthy aging and fertility, the effect of lifestyle related
components like lipid or carbohydrate metabolites in follicular fluid on IVF
outcome parameters are of our current interest. In cows, the dietary n-6:n-3
fatty acid ratio alters the follicular fluid fatty acid profile and affects
oocyte quality. Data about a direct relation between nutrition and follicular
fluid composition are however limited, especially in humans, as is its relation
with IVF outcome. Further, it is as yet unclear whether such diet induced
changes in follicular fluid composition are related to diffusion of factors
from the blood into the follicular fluid, or to altered granulosa cell
metabolism and secretion into the follicular fluid.
.
Study objective
Our primary objective is to assess whether maternal nutrition is reflected in
serum and follicular fluid composition, and whether this affects IVF outcome.
Our secondary objectives are a) to assess whether nutrition related follicular
fluid composition differences are related to serum alterations and/or to an
altered local metabolism in granulosa cells and b) to investigate
intra-individual differences in follicular fluid composition and how these
relate to IVF outcomes.
Study design
In this observational study, patients attending for a modified natural cycle
(MNC) IVF treatment will be recruited for participation. The modified natural
cycle IVF treatment itself will be performed as usual. Further, the women will
be asked to fill in a food diary on the days between the achievement of a
dominant follicle (~14mm) and the day of ovum-pick up (on average four days).
At the day of ovum-pick up a blood sample of 10cc will be drawn, for which the
patient has to have an empty stomach. After the ovum pick-up, when the oocyte
is collected at the IVF laboratory for patient care, the follicular fluid and
granulosa cells which would normally be discarded, will be stored for later
analysis. The level of metabolism related components (mainly lipid and
carbohydrate metabolism) will be determined in follicular fluid and the blood
samples. These will be mutually compared and related to the nutrition of the
woman and their IVF outcomes.
Study burden and risks
Participation does not affect the IVF-treatment of the patient in any way nor
will it benefit the patient in any way. The only discomfort consists of filling
in a food diary in four days on average preceding the oocyte pick-up and in the
collection of one extra tube of blood of 10 cc at the day of ovum pick-up.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
All women attending the IVF clinic for their first course of at most six cycles of modified natural cycle with IVF or ICSI (MNC -IVF) ever or after a pregnancy
Exclusion criteria
polycystic ovary syndrome (PCOS)
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 | NL47569.042.13 |
OMON | NL-OMON29551 |