NCT03184519

Completed

Comparison of hhCG With hCG+ß in the Early Prediction of Ong...

Instituto Valenciano de Infertilidad, IVI VALENCIA Source

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

1701-VLC-011-EB

Study Type

interventional

Actual enrollment (reported)

156

Locations

1 country

Sites

1

Timeline

Study Start

June 19, 2017

Actual (reported)

Primary Completion

August 10, 2018

Actual (reported)

Study Completion

August 10, 2018

Actual (reported)

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).

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 156 participants
Study completion date: August 10, 2018
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
June 9, 2017
Actual (reported)
First Posted
June 12, 2017
Actual (reported)
Study Start
June 19, 2017
Actual (reported)
Primary Completion
August 10, 2018
Actual (reported)
Study Completion
August 10, 2018
Actual (reported)
Results Posted
March 4, 2020
Actual (reported)

Last Updated: August 13, 2020
Status Verified: July 2020
Results QC Date: February 18, 2020
Last Update Submitted: 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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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

Sponsors & Collaborators

Instituto Valenciano de Infertilidad, IVI VALENCIA
Otherlead

Study Sites (1)

IVI Valencia

Valencia, 46003, Spain

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

Study Officials

Ernesto Bosch, MDPhD
IVIRMA VALENCIA
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

156 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: DIAGNOSTIC
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 9, 2017

First Posted

June 12, 2017

Study Start

June 19, 2017

Actual (reported)

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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.

Primary Completion

August 10, 2018

Actual (reported)

Study Completion

August 10, 2018

Actual (reported)

Last Updated

August 13, 2020

Results First Posted

March 4, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT03184519
Data provider: ClinicalTrials.gov
Source updated: 2020-08-13
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:17:42 UTC

Documents

Study Protocol and Statistical Analysis Plan
ProtocolSAP2017-05-09

Locations

ES(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

All patients

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations