The main objective of this study is to measure the human uterine temperature and pH and to analyze the composition of aspirated uterine fluid of 30 women of reproductive age from a Dutch population three or four days after ovulation.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
baarmoederomstandigheden en IVF behandeling
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study outcomes will be the mean (SD) temperature and the mean (SD) pH
measured in the uterine cavity of women from a Dutch population at the time of
the menstrual cycle an embryo normally implants, and the average concentration
(mean ± SEM) of at least thirty-seven components present in fluid aspirated
from the uteri of the same women at the same time.
Secondary outcome
The difference between the primary results and previous results from the uteri
of Iranian women and the difference between the primary results and the current
human embryo culture conditions for human IVF, determined with an independent
T-test (temperature and pH) or one-way ANOVA (uterine fluid components).
Background summary
In vitro fertilization (IVF) has revolutionized reproductive medicine.
Currently around 2 million IVF treatments are provided worldwide each year.
However, only about one third of all treatments started results in live birth.
There is a strong incentive to optimize embryo culture conditions in order to
improve IVF efficacy. In the development and optimization of embryo culture
conditions in human IVF the use of mouse embryos have been playing a dominant
role. Limited research has been performed on the human in vivo environment of
preimplantation embryos, leaving substantial gaps in our knowledge of the
optimal conditions for human embryo development. Therefore, new studies
elucidating the natural environment of human preimplantation embryos in vivo
are urgently needed to enable mimicking of the natural environment in vitro. It
is expected that this will improve human embryo quality and subsequently IVF
efficacy (higher pregnancy rates) and safety (the health of IVF children).
Our research group previously measured physiological conditions - temperature
and pH - in the uterus of 53 Iranian women during the implantation window, i.e.
the window of the menstrual cycle in which implantation of the embryo would
normally take place, and analyzed 22 uterine fluid samples on the presence and
concentration of 37 components. This resulted in clear clues on how to improve
IVF culture conditions. However, additional research is required to confirm
these results in women from a different population and thereby exclude
(epi)genetic and/or nutritional effects on uterine characteristics.
Study objective
The main objective of this study is to measure the human uterine temperature
and pH and to analyze the composition of aspirated uterine fluid of 30 women of
reproductive age from a Dutch population three or four days after ovulation.
Study design
Observational study.
Participants will monitor their ovulation with a urine dipstick LH-test and pay
an extra visit to the Center of Reproductive Medicine at Amsterdam UMC,
location AMC for the uterine measurements. Three or four days after ovulation
the temperature and pH will be measured in the uterine cavity with a
temperature probe and a pH catheter through an outer cathether. Also uterine
fluid will be aspirated at that time and later analysed on the presence of at
least thirty-seven components. Results will be compared with previous results
obtained from a different population of Iranian women and also with the embryo
culture conditions currently used in human IVF. This study will thereby
demonstrate whether there is a difference in uterine characteristics between
women with different (epi)genetic and nutritional backgrounds. With the
knowledge from these studies we will then improve current human embryo culture
conditions.
Study burden and risks
The risk and burden on the subjects in this study are considered to be minimal.
Participants will make an additional visit to the hospital for uterine
measurements and uterine fluid aspiration. From our previous study in which the
same procedures were performed, we know that the risk of side effects is
negligible. In addition, a risk inventory has been carried out. It is possible
that participants will experience discomfort from uterine contractions after
the procedure, which is comparable to the possible discomfort after an embryo
transfer. There is no direct benefit from this study to the participants in
this study. After participating in this study, participants will receive
standard fertility treatment. The results of this study are solely for
scientific enrichment and will be substantial in our understanding of the
natural embryonic environment in humans and will be used to optimize the
current human embryo culture system used in general in clinical IVF.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
Reproductive age (18-43 years old)
Regular menstrual cycle
Normal transvaginal ultrasound
Planned ICSI treatment due to (severe) male factor subfertility or planned
fertility treatment with donor sperm
Written informed consent
Exclusion criteria
Unexplained subfertility, tubal infertility or premature ovarian failure
The presence of untreated unilateral or bilateral hydrosalpinx
A history of dilatation and curettage
Previous caesarean section with niche formation
Malformation of the urogenital system
Endometriosis
Untreated/unsubstituted endocrine abnormalities (e.g. pituitary, thyroid,
adrenal or pancreas abnormalities).
PCOS
Design
Recruitment
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
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In other registers
| Register | ID |
|---|---|
| CCMO | NL76759.018.22 |