Pregnancy Clinical Trial
— PEP-cohortOfficial title:
Prospective Early Pregnancy Cohort and Preimplantation Factor: Factors Related to Successful Implantation, Risk of Miscarriage and Recurrent Pregnancy Loss in the First Trimester
NCT number | NCT02761772 |
Other study ID # | PEP-PIF-2016 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 2016 |
Est. completion date | December 31, 2018 |
Verified date | March 2019 |
Source | Nordsjaellands Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 210 |
Est. completion date | December 31, 2018 |
Est. primary completion date | September 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
PEP-A Inclusion Criteria: 1. Women in ART treatment by natural cycle frozen embryo transfer only monitored by urine LH. 2. Age above 18 years. 3. Ability to understand read and write Danish for the informed consent. 4. Planned delivery at the hospitals involved in the project. Exclusion Criteria: 1. Abnormal uterine anatomy or function already known or estimated at first transvaginal ultrasonography. 2. History of recurrent pregnancy loss. 3. Ongoing or former (at least 12 months of no use) narcotics or alcohol abuse (above 14 units of alcohol per week). 4. Contraindication for pregnancy. PEP-S Inclusion Criteria: 1. Spontaneous pregnancy in women above 18 years of age. 2. Gestational age of singleton pregnancy below full eight weeks by first transvaginal ultrasound. 3. Ability to understand read and write Danish for the informed consent. 4. Planned delivery at the hospitals involved in the project. Exclusion Criteria: 1. All types of ART treatment in the actual pregnancy. 2. Abnormal uterine anatomy or function already known or estimated at first transvaginal ultrasonography. 3. History of recurrent pregnancy loss. 4. Ongoing or former (at least 12 months of no use) narcotics or alcohol abuse (above 14 units of alcohol per week). 5. Contraindication for pregnancy. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Nordsjaellands Hospital | BioIncept LLC, Rigshospitalet, Denmark, Yale University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Research biobank for future use | Establishment of a robust research biobank for future studies in blood derived conditions in the first trimester of pregnancy | During 2017 | |
Primary | PIF in PEP-A | Serum PIF by gestational age in the luteal phase | During 2018 | |
Primary | Prediction model for the risk of spontaneous abortion | The ability of serum PIF to predict viability of natural pregnancies with and without other biomarkers, ultrasonographys and medical history data. | During 2018 | |
Primary | PIF and recurrent pregnancy loss (RPL) | Serum PIF levels in a unique retrospective cohort of RPL patients | Late 2018 | |
Secondary | Hormonal development in the luteal phase | Descriptive overview of natural hormones in the luteal phase and their ability to predict pregnancy and live birth rates | During 2018 |
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