Pregnancy Clinical Trial
Official title:
Prospective Early Pregnancy Cohort and Preimplantation Factor: Factors Related to Successful Implantation, Risk of Miscarriage and Recurrent Pregnancy Loss in the First Trimester
Miscarriage is a common event associated with severe psychological and social morbidity,
further tormenting in women suffering recurrent pregnancy loss (RPL) by at least three
consecutive losses.
Ultrasonography and biomarkers have yet to precisely predict viability in pregnancies with
symptoms of threatening miscarriage.
A novel biomarker Preimplantation Factor (PIF) derived by the developing embryo might be the
key factor for this prediction ameliorating the implantation process by promoting a favorable
local immune system in the uterus.
The investigators aim to establish a prospective early pregnancy cohort (PEP-cohort) that
includes women throughout the first trimester by both assisted reproductive technology (ART)
and spontaneous conceptions. By a combination of consecutive ultrasonographys and blood
samples of known predictors of implantation PIF as a predictor of viability will be
evaluated.
These data are finally compared to the same data in a retrospective cohort of RPL patients
emphasizing the role of PIF.
All collected data will be stored in a Research Biobank for the current studies outlined as
well as potential future studies of reproductive medicine in the first trimester.
The investigators aim to evaluate Preimplantation Factor (PIF) throughout the first trimester
we need to employ two settings of recruitment.
Early part:
The PEP in ART (PEP-A) will enroll participants referred for fertility treatment at
Rigshospitalet and North Zealand Hospital. Participants all have cryopreserved embryos
suitable for frozen embryo transfer in a natural menstrual cycle. No type of ovulation
trigger will be employed, as the LH peak is monitored via home urine-LH test.
For a thorough examination of the luteal phase, participants are recalled for blood samples
on day 7, 11, 14 and 16 after positive urine-LH test. Hereafter positive serum human
chorionic gonadotropin (hCG) denotes a pregnancy and these participants are offered to
continue in the later part of the PEP-cohort.
Late part:
PEP in Spontaneous conceptions (PEP-S) represents the sampling of expected normal pregnancies
from the local community. Enrolled at the time of the first positive pregnancy test,
participants are expected to be included from approximately 5 weeks of gestation. Hereafter
participants are recalled every two weeks for blood sampling and transvaginal
ultrasonographys of endometrial thickness until a gestational sac and yolk sac are visible
for mean sac diameter measuring and eventually the crown-rump-length.
Research biobank All collected data: questionnaires of medical history before enrollment,
ultrasonographys and blood samples of progesterone, 17-OH-progesterone, estradiol,
alpha-feto-protein (AFP), pregnancy associated placental protein A (PAPP-A), hCG and PIF are
stored in a research biobank.
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