Comparison of hhCG With hCG+ß in the Early Prediction of Ongoing Pregnancy. (hyperPOC)

Comparison of hhCG With hCG+ß in the Early Prediction of Ongoing Pregnancy After In-vitro Fertilization and Embryo Transfer.

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).

Study Overview

• Status: Completed
• Conditions: Pregnancy Test
• Intervention / Treatment: Diagnostic test: Pregnancy test

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46003
    • IVI Valencia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion criteria:

• 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)

Exclusion criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All patients; Patients will undergo 3 blood samples after IVF-ET (pregnancy test) to determine pregnancy.	Diagnostic test: Pregnancy test; Instead of one blood sample, patients will have three blood analyses to predict pregnancy earlier after the embryo transfer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Early Detection of Pregnancy	Detection of Pregnancy on earlier dates (before day-11 after Embrio transfer)	One month

Collaborators and Investigators

• Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
• Investigators: Principal Investigator: Ernesto Bosch, MDPhD, IVIRMA Valencia

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2017
• Primary Completion (Actual): August 10, 2018
• Study Completion (Actual): August 10, 2018

Study Registration Dates

• First Submitted: June 9, 2017
• First Submitted That Met QC Criteria: June 9, 2017
• First Posted (Actual): June 12, 2017

Study Record Updates

• Last Update Posted (Actual): August 13, 2020
• Last Update Submitted That Met QC Criteria: July 30, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 1701-VLC-011-EB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No