Luteal PhasePEP-cohortNCT02761772
Early Pregnancy Cohort and Preimplantation Factor
An observational study of Luteal Phase and Biomarkers, run by Nordsjaellands Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Luteal Phase, Biomarkers, Abortion, Spontaneous
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to 31 Dec 2018
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: PEP-A: Women in ART treatment by natural cycles of frozen embryo transfer at North Zealand Hospital and Rigshospitalet. PEP-S: Women with a positive pregnancy test by spontaneous conception, prior to eight weeks of gestation.
Who may be able to join
- Women in ART treatment by natural cycle frozen embryo transfer only monitored by urine LH.
- Age above 18 years.
- Ability to understand read and write Danish for the informed consent.
- Planned delivery at the hospitals involved in the project.
- Spontaneous pregnancy in women above 18 years of age.
- Gestational age of singleton pregnancy below full eight weeks by first transvaginal ultrasound.
- Ability to understand read and write Danish for the informed consent.
- Planned delivery at the hospitals involved in the project.
Who cannot join
- Abnormal uterine anatomy or function already known or estimated at first transvaginal ultrasonography.
- History of recurrent pregnancy loss.
- Ongoing or former (at least 12 months of no use) narcotics or alcohol abuse (above 14 units of alcohol per week).
- Contraindication for pregnancy.
- PEP-S
- All types of ART treatment in the actual pregnancy.
Show all 10Show fewer
- Abnormal uterine anatomy or function already known or estimated at first transvaginal ultrasonography.
- History of recurrent pregnancy loss.
- Ongoing or former (at least 12 months of no use) narcotics or alcohol abuse (above 14 units of alcohol per week).
- Contraindication for pregnancy.
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Luteal Phase, Biomarkers, Abortion, Spontaneous, Abortion, Habitual, Pregnancy
- Keywords
- Preimplantation Factor
- Medical subject headings
- Abortion, Spontaneous, Abortion, Habitual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PEP-A | See detailed description | |
| PEP-S | See detailed description |
What is being measured
The primary outcome is the main question the study is designed to answer.
PIF in PEP-A
Serum PIF by gestational age in the luteal phase
Measured: During 2018
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.
Measured: During 2018
PIF and recurrent pregnancy loss (RPL)
Serum PIF levels in a unique retrospective cohort of RPL patients
Measured: Late 2018
Secondary outcomes (1)
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
Measured: During 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startApr 2016
- Primary completionSep 2017
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Luteal PhaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Yale University, BioIncept LLC
- Responsible party
- Principal investigator, Jesper Friis Petersen, Nordsjaellands Hospital
- Investigators
- Jesper F Petersen, M. D., Principal investigator, Nordsjaellands Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02761772
- Sponsor's protocol ID
- PEP-PIF-2016
- Acronym
- PEP-cohort
- Status last verified
- Mar 2019
- First submitted
- 2 May 2016
- Last updated
- 27 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Following collection, data are planned to be shared within a global archive.
Publications
Petersen JF, Friis-Hansen LJ, Bryndorf T, Jensen AK, Andersen AN, Lokkegaard E. A Novel Approach to Predicting Early Pregnancy Outcomes Dynamically in a Prospective Cohort Using Repeated Ultrasound and Serum Biomarkers. Reprod Sci. 2023 Dec;30(12):3597-3609. doi: 10.1007/s43032-023-01323-8. Epub 2023 Aug 28.
PubMed 37640889
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02761772
- Acronym / sponsor ID
- PEP-cohort / PEP-PIF-2016
- Conditions
- Luteal Phase, Biomarkers, Abortion, Spontaneous, Abortion, Habitual, Pregnancy
- Keywords
- Preimplantation Factor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Yale University, BioIncept LLC
- Study start
- Apr 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 4 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEP-A | – | –See detailed description |
| PEP-S | – | –See detailed description |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- PEP-A: Women in ART treatment by natural cycles of frozen embryo transfer at North Zealand Hospital and Rigshospitalet. PEP-S: Women with a positive pregnancy test by spontaneous conception, prior to eight weeks of gestation.
Key inclusion criteria (8 listed)
- Women in ART treatment by natural cycle frozen embryo transfer only monitored by urine LH.
- Age above 18 years.
- Ability to understand read and write Danish for the informed consent.
- Planned delivery at the hospitals involved in the project.
- Spontaneous pregnancy in women above 18 years of age.
Key exclusion criteria (10 listed)
- Abnormal uterine anatomy or function already known or estimated at first transvaginal ultrasonography.
- History of recurrent pregnancy loss.
- Ongoing or former (at least 12 months of no use) narcotics or alcohol abuse (above 14 units of alcohol per week).
- Contraindication for pregnancy.
- PEP-S
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PIF in PEP-A
Time frame: During 2018
Serum PIF by gestational age in the luteal phase
Prediction model for the risk of spontaneous abortion
Time frame: During 2018
The ability of serum PIF to predict viability of natural pregnancies with and without other biomarkers, ultrasonographys and medical history data.
PIF and recurrent pregnancy loss (RPL)
Time frame: Late 2018
Serum PIF levels in a unique retrospective cohort of RPL patients
1 secondary outcome
Hormonal development in the luteal phase
Time frame: During 2018
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
- Derived from this study: PubMed 37640889Petersen JF, Friis-Hansen LJ, Bryndorf T, Jensen AK, Andersen AN, Lokkegaard E. A Novel Approach to Predicting Early Pregnancy Outcomes Dynamically in a Prospective Cohort Using Repeated Ultrasound and Serum Biomarkers. Reprod Sci. 2023 Dec;30(12):3597-3609. doi: 10.1007/s43032-023-01323-8. Epub 2023 Aug 28.
- Individual participant dataSharing planned: Yes. Following collection, data are planned to be shared within a global archive.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesper F Petersen, M. D. principal investigator
Nordsjaellands Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Luteal Phase and Biomarkers, run by Nordsjaellands Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PIF in PEP-A (time frame: During 2018). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02761772, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2019.