The goal of this study is to elucidate whether there is a difference in endometrial parameters (determining endometrial receptivity) between women with reproductive failure: RIF and RM. Secondly we will investigate how the endometrial parameters of…
ID
Source
Brief title
Condition
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are steroid profile in endometrial tissue and serum,
activity of steroid enzymes, phenotype and function of Natural Killer cells,
presence of HLA antibodies, determination of the vaginal microbiome and
volatile organic compounds.
Secondary outcome
Not applicable
Background summary
Women with recurrent unexplained miscarriage (RM) and repeated implantation
failure (RIF) are proposed to be at opposite ends of the implantation spectrum,
with too receptive endometrium (implantation of genetically aberrant or poor
quality embryos) versus too selective endometrium (no implantation even with
genetically normal or good quality embryos). In both cases, no explanation for
unsuccessful implantation has been found yet. Therefore, doctors can provide no
therapeutic options other than supportive care on the way to a subsequent
pregnancy.
Study objective
The goal of this study is to elucidate whether there is a difference in
endometrial parameters (determining endometrial receptivity) between women with
reproductive failure: RIF and RM. Secondly we will investigate how the
endometrial parameters of the women with RIF and unexplained RM compare with
those of healthy, fertile women with a fertility treatment indication for
another cause (such as male infertility or PGD).
Study design
This is a single-centre, observational cohort study. We will draw blood once,
take a single endometrial biopsy and vaginal swab, and collect menstrual blood
once to determine the endometrial profile of these women.
Study burden and risks
Women with RÏF, RM or fertile controls are invited for 1 extra visit to the
MUMC+ for an endometrial biopsy, one blood sample and a vaginal swab. They
receive a mooncup for collection of menstrual blood at home. From existing
literature it is clear that the rate of adverse events is very low. It is of
great importance to gain more insight in the physiology of embryo implantation
and the pathofysiological processes that occur when an embryo fails to implant
(no implantation, or repeated miscarriages). We lack diagnostical tools to
discover the cause of reproductive failure in this category of women, which is
an enormous emotional burden for these patients. By means of this study,
attempts are made for the first time to gain more insight in these processes of
implantation in women with succesful implantation in the past, repeated
implantation failure and repeated miscarriages. Besides, there might be a small
benefit for all participants as taking an endometrial biopsy could induce a
higher change of pregnancy in subsequent menstrual cycles.
P. Debyelaan 25
Maastricht 6229HX
NL
P. Debyelaan 25
Maastricht 6229HX
NL
Listed location countries
Age
Inclusion criteria
Repeated implantation failure
- Female aged 18-38 years old
- Repeated implantation failure (RIF) defined as:
- failure of implantation of three high quality embryo*s or after placement of
ten or more embryo*s in multiple transfers
- Primary or secondary infertility
- Written informed consent
Recurrent miscarriages
- Female aged 18-38 years old
- Repeated, unexplained miscarriages (RM) defined as 2 or more unexplained
miscarriages not caused by abnormal parental karyotype, maternal thrombophilia
and/or uterine abnormalities
- Written informed consent
Control
- Female aged 18-38 years old
- Uneventful previous pregnancy defined as no preterm delivery, pre-eclampsia
or fetal growth restriction and live birth OR presumed fertile defined as an
indication for PESA/TESE, female sterilisation, or PGD indication for genetic
analysis without subfertility treatment
- Written informed consent
Exclusion criteria
Repeated implantation failure
- Clinically relevant intra-uterine pathology
- BMI > 35 kg/m2
- Untreated endocrine abnormalities
- PGD treatment
Recurrent miscarriages
- Current or recent (<3 months ago) pregnancy, breastfeeding or hormonal
contraceptive
- Current symptomatic genital infection
- BMI > 35 kg/m2
Control group
- Recurrent miscarriages or repeated implantation failure
- Current or recent (<3 months ago) pregnancy, breastfeeding or current
hormonal contraceptive use
- BMI > 35 kg/m2
- Severe endometriosis (3th -4th degree)
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 | NL66835.068.18 |
| OMON | NL-OMON24778 |