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

NCT ID: NCT03184519

Last Updated: 2020-08-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-19

Study Completion Date

2018-08-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pregnancy Test

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

All patients

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

Group Type EXPERIMENTAL

Pregnancy test

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pregnancy test

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Instituto Valenciano de Infertilidad, IVI VALENCIA

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ernesto Bosch, MDPhD

Role: PRINCIPAL_INVESTIGATOR

IVIRMA VALENCIA

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

IVI Valencia

Valencia, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1701-VLC-011-EB

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.