Comparison of hhCG With hCG+ß


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Verified June 2017 by Instituto Valenciano de Infertilidad, IVI VALENCIA

Sponsor:

Information provided by (Responsible Party):

Instituto Valenciano de Infertilidad, IVI VALENCIA

ClinicalTrials.gov Identifier:

NCT03184519

First received: June 9, 2017

Last updated: June 9, 2017

Last verified: June 2017

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).

Pregnancy Detection Diagnostic Test: Pregnancy test

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:

All the patients will undergo 3 blood samples for analyses to determine pregnancy.

Masking: No masking
Primary Purpose: Diagnostic

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

Primary Outcome Measures:

Estimated Enrollment: 136
Anticipated Study Start Date: June 19, 2017
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Experimental: All patients

Patients will undergo 3 blood samples after IVF-ET 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.

Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Written informed consent
  • Patients undergoing their first or second IVF-ET cycle
  • Age 18-42 years
  • Use of Ovitrelle for final follicular maturation and luteinization
  • Fresh IVF cycle transfer of day-5 embryos (5 days after fertilization of the egg)

Exclusion criteria:

  • Egg donation
  • Gestational surrogacy
  • Cryocycles (frozen embryo transfer)
  • Canceled IVF cycles
  • GnRH agonist triggering cycles

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03184519

Instituto Valenciano de Infertilidad, IVI VALENCIA

Responsible Party: Instituto Valenciano de Infertilidad, IVI VALENCIA
ClinicalTrials.gov Identifier: NCT03184519     History of Changes
Other Study ID Numbers: 1701-VLC-011-EB
Study First Received: June 9, 2017
Last Updated: June 9, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

ClinicalTrials.gov processed this record on June 12, 2017