Early Pregnancy Cohort and Preimplantation Factor

NCT02761772 | Completed DMC

• 1 other identifier: PEP-PIF-2016
• Study Type: observational
• Target: 210
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Luteal Phase; Biomarkers; Abortion, Spontaneous; Abortion, Habitual; Pregnancy

Keywords

Preimplantation Factor

Outcome Measures

Primary Outcomes (3)

• PIF in PEP-A

  Serum PIF by gestational age in the luteal phase

  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.

  During 2018

• PIF and recurrent pregnancy loss (RPL)

  Serum PIF levels in a unique retrospective cohort of RPL patients

  Late 2018

Secondary Outcomes (1)

• Hormonal development in the luteal phase

  During 2018

Other Outcomes (1)

• Research biobank for future use

  During 2017

Study Arms (2)

PEP-A

See detailed description

PEP-S

See detailed description

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.
• All types of ART treatment in the actual pregnancy.
• 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.

Sponsors & Collaborators

• Nordsjaellands Hospital: lead
• Rigshospitalet, Denmark: collaborator
• Yale University: collaborator
• BioIncept LLC: collaborator

Related Publications (1)

• 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.

  PMID: 37640889 DERIVED

MeSH Terms

Conditions

Abortion, Spontaneous; Abortion, Habitual

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Jesper F Petersen, M. D.

  Nordsjaellands Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., PhD student

Study Record Dates

• First Submitted: May 2, 2016
• First Posted: May 4, 2016
• Study Start: April 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: December 31, 2018
• Last Updated: March 27, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share