Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05865015 |
| Other study ID # |
TP20210218 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 5, 2023 |
| Est. completion date |
September 10, 2023 |
Study information
| Verified date |
February 2024 |
| Source |
University Medical Centre Ljubljana |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Infertility affects around 15 % of couples in their reproductive years. Even though the use
of assisted reproductive technologies (ART) in aforementioned couples is increasing, their
success rate is still relatively low. Hence it is important to identify and better understand
potential modifiable dietary and lifestyle risk factors that may influence the success of
ART. This study will include women undergoing IVF with a view to investigating the
relationship between preconception dietary patterns, body composition, physical activity
level, serum values of vitamin B9, vitamin B12 and vitamin D and the outcomes of IVF, such as
the number of obtained oocytes, fertilization rate and clinical pregnancy. Main hypothesis is
that women undergoing IVF, who eat a balanced diet, maintain healthy body weight and have
adequate serum levels of vitamin B9, vitamin B12 and vitamin D, have a higher chance of
achieving better IVF outcomes.
Description:
Infertility, which affects around 15 % of couples of reproductive, refers to the inability of
a couple to conceive after 12 months of unprotected sex. Pre-conception dietary habits have
been shown to influence the outcomes of the in vitro fertilization (IVF) procedure, such as
oocyte and embryo quality, embryo implantation and successful pregnancy. Thus far, a balanced
diet, especially a Mediterranean diet (MED), is known to have a beneficial effect on the
outcome of IVF in women before the IVF process. MED is characterised by a high intake of
antioxidants that reduces oxidative stress, which otherwise increases the likelihood of
infertility in women. In addition, the Mediterranean diet is characterised by a higher intake
of folate and polyunsaturated omega-3 fatty acids (especially eicosapentaenoic acid), which
also has a beneficial effect on the outcome of the IVF process. While some authors have not
confirmed that the Mediterranean diet can increase the likelihood of pregnancy after IVF in
infertile women, they have found that it can increase the number of embryos ready for
transfer. On the other hand, an unbalanced diet with a typically low intake of vitamins and
minerals has an adverse effect on fertility. Low intakes of vitamins B6, B9 and B12 are
particularly problematic, as their deficiency leads to the accumulation of homocysteine,
which can lead to hyperhomocysteinemia. Elevated levels of homocysteine in follicular fluid
are known to negatively affect the number of retrieved oocytes and embryo quality in IVF and
intracytoplasmic sperm injection (ICSI). Higher serum levels of vitamin B9 and vitamin B12 in
women have been shown to increase the likelihood of a live birth after ART, as they have a
beneficial effect on pregnancy maintenance after embryo implantation. Despite the known
importance of sufficient vitamin B9 and vitamin B12 intake to support fertility and success
of the IVF procedure, some women undergoing IVF still have largely insufficient serum levels
of vitamin B9 and vitamin B12 prior to the IVF procedure. Vitamin D deficiency in women has
also been identified as a modifiable risk factor that may affect the outcome of ART. Vitamin
D is involved in steroid formation in the ovary and in the expression of genes in the
endometrium that are crucial for embryo implantation. For this reason, women should have
their serum vitamin D levels routinely checked before IVF. This would allow women with an
identified vitamin D deficiency to start vitamin D supplementation, which may have a
beneficial effect on IVF outcome. Another modifiable factor with an impact on ART outcome is
excessive body weight and obesity, as adipose tissue interferes with the synthesis and
bioavailability of sex hormones in women, which negatively affects oocyte quality and
endometrial receptivity. In this group of women, oocytes are less likely to properly develop
after IVF than oocytes from women with optimal body weight. In addition, it is known that
women who are overweight or obese have a lower probability of embryo implantation, clinical
pregnancy and live birth after IVF/ICSI. However, in women with obesity, regular physical
activity can have a positive effect on IVF/ICSI outcomes even when body mass index is
unchanged. Consequently, the time before the ART procedure presents an opportunity to
establish nutritional counselling to facilitate women's achievement of optimal body weight
and intake of the necessary micronutrients, which could positively influence the outcome of
the ART procedure. However further studies on the impact of women's dietary habits and
nutritional status on the outcome of the ART procedure are urgently needed before this can be
done.
The investigators aim to identify which modifiable risk factors for IVF/ICSI failure are
poorly managed in women and to improve understanding of the impact of women's dietary habits,
physical. The investigators are interested in whether women have a balanced diet before the
IVF/ICSI procedure and whether they successfully prevent vitamin B9, vitamin B12 and vitamin
D deficiencies, which can negatively affects the outcomes of IVF/ICSI. By measuring women's
body composition before IVF/ICSI, the investigators aim to test whether an excessive
percentage of fat mass reduces the likelihood of IVF/ICSI success, as suggested by the
scientific evidence to date. The information obtained will allow the design of future
nutritional counselling for women before IVF/ICSI to facilitate the establishment of a
healthier lifestyle and potentially increase the likelihood of success of the IVF/ICSI
procedure, thereby reducing the economic burden of infertility treatment. In the first study
of its kind in Slovenia, the investigators expect to identify the association between dietary
habits, physical activity levels, body composition and serum levels of vitamin B9, vitamin
B12 and vitamin D and IVF/ICSI outcomes, such as the number of retrieved oocytes, the rate of
fertilisation of oocytes and clinical pregnancy, in women prior to undergoing IVF/ICSI. The
underlying hypothesis is that women who have a balanced diet and lead a healthier lifestyle
prior to IVF/ICSI will have a higher likelihood of favourable IVF/ICSI outcomes.
The research will be conducted at the Clinical Department of Reproduction, Department of
Gynaecology, University Clinical Centre Ljubljana, with the collaboration of the Faculty of
Biotechnology, University of Ljubljana. The study will be cross-sectional,
non-interventional. Patients will be introduced to the study and its process at the time of
entering the IVF/ICSI procedure. If the patient signs the informed consent form, the
investigators will obtain her height and weight measurement and body composition measurement
by non-invasive bioimpedance analysis. The patient will also fill in the questionnaire
required for the study, which includes questions regarding sociodemographic status, dietary
habits, frequency of food consumption in the past month, and physical activity level. In
addition, prior to the IVF/ICSI procedure, the patient will have blood drawn for biochemical
laboratory tests at the Clinical Institute of Clinical Chemistry and Biochemistry, University
Clinical Centre Ljubljana (in addition to the standard tests, the investigators will also
determine vitamin B9 or folate and folic acid, vitamin B12, vitamin D, oligoelements, heavy
metals, hormone disruptors, etc.) The protection of personal data will be guaranteed, as each
blood sample will be labelled or recorded during the study under a code identical to the code
of the questionnaire completed by the patient. Information on the results of the IVF/ICSI
procedure will be obtained from the patients' medical records with their consent. Statistical
evaluation of the data will be performed at the Faculty of Biotechnology, University of
Ljubljana. The data obtained will be subjected to appropriate statistical analysis to
determine the association of dietary habits, body composition, physical activity level and
serum vitamin B9, vitamin B12 and vitamin D levels of patients before the IVF/ICS procedure
on IVF/ICS outcomes.
