NCT03184519

Brief Summary

Proof of concept study for the prediction of ongoing pregnancy in women undergoing In-Vitro Fertilization (IVF), using hyperglycosylated human chorionic gonadotropin (hhCG), early after In-Vitro Fertilization and fresh Embryo Transfer (IVF-ET).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

June 19, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2018

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

March 4, 2020

Completed
Last Updated

August 13, 2020

Status Verified

July 1, 2020

Enrollment Period

1.1 years

First QC Date

June 9, 2017

Results QC Date

January 7, 2020

Last Update Submit

July 30, 2020

Conditions

Pregnancy Test

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Early Detection of Pregnancy

    Detection of Pregnancy on earlier dates (before day-11 after Embrio transfer)

    One month

Study Arms (1)

All patients

EXPERIMENTAL

Patients will undergo 3 blood samples after IVF-ET (pregnancy test) to determine pregnancy.

Diagnostic Test: Pregnancy test

Interventions

Pregnancy testDIAGNOSTIC_TEST

Instead of one blood sample, patients will have three blood analyses to predict pregnancy earlier after the embryo transfer.

All patients

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Written informed consent
  • Patients undergoing their first or second IVF-ET cycle
  • Age 18-45 years
  • Use of Ovitrelle for final follicular maturation and luteinization
  • Fresh or Frozen day-5 blastocysts transrer (Autologus or Egg donation)

You may not qualify if:

  • Gestational surrogacy (patient's eggs used for pregnancy in a surrogate mother)
  • Canceled IVF cycles
  • GnRH agonist triggering cycles in the case of fresh ET.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IVI Valencia

Valencia, 46003, Spain

Location

MeSH Terms

Interventions

Pregnancy Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, Obstetrical and GynecologicalInvestigative Techniques

Results Point of Contact

Title
LAURA CARACENA (STUDY COORDINATOR)
Organization
IVIValencia
laura.caracena@ivirma.com
034 963050900

Study Officials

  • Ernesto Bosch, MDPhD

    IVIRMA VALENCIA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: All the patients will undergo 3 blood samples for analyses to determine pregnancy.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2017

First Posted

June 12, 2017

Study Start

June 19, 2017

Primary Completion

August 10, 2018

Study Completion

August 10, 2018

Last Updated

August 13, 2020

Results First Posted

March 4, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)