Pregnancy TesthyperPOCNCT03184519
Comparison of hhCG With hCG+ß in the Early Prediction of Ongoing Pregnancy.
A study testing Pregnancy test in people with Pregnancy Test, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pregnancy Test
- What is being tested?
- Pregnancy test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteSpain
- Study dates
- 19 Jun 2017to 10 Aug 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Pregnancy Test
- Being tested
- Pregnancy test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregnancy testDiagnostic test
Instead of one blood sample, patients will have three blood analyses to predict pregnancy earlier after the embryo transfer.
| Study group | Role | What they receive |
|---|---|---|
| All patients | Experimental | Patients will undergo 3 blood samples after IVF-ET (pregnancy test) to determine pregnancy. Receives: Diagnostic Test: Pregnancy test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Early Detection of Pregnancy
Detection of Pregnancy on earlier dates (before day-11 after Embrio transfer)
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start19 Jun 2017
- Primary completion10 Aug 2018
- Study completion10 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pregnancy TestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All the patients will undergo 3 blood samples for analyses to determine pregnancy.
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ernesto Bosch, MDPhD, Principal investigator, IVIRMA VALENCIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03184519
- Sponsor's protocol ID
- 1701-VLC-011-EB
- Acronym
- hyperPOC
- Status last verified
- Jul 2020
- First submitted
- 9 Jun 2017
- Last updated
- 13 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of hhCG With hCG+ß in the Early Prediction of Ongoing Pregnancy After In-vitro Fertilization and Embryo Transfer.
- ClinicalTrials.gov ID
- NCT03184519
- Acronym / sponsor ID
- hyperPOC / 1701-VLC-011-EB
- Conditions
- Pregnancy Test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
- Study start
- 19 Jun 2017 (actual)
- Primary completion
- 10 Aug 2018 (actual)
- Study completion
- 10 Aug 2018 (actual)
- First posted
- 12 Jun 2017 (actual)
- Results
- Posted 4 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All the patients will undergo 3 blood samples for analyses to determine pregnancy.
| Arm | Type | Receives |
|---|---|---|
| All patients | Experimental | Diagnostic Test: Pregnancy testPatients will undergo 3 blood samples after IVF-ET (pregnancy test) to determine pregnancy. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pregnancy testInstead of one blood sample, patients will have three blood analyses to predict pregnancy earlier after the embryo transfer. | Diagnostic test | All patients |
Primary outcome
Number of Participants With Early Detection of Pregnancy
Time frame: One month
Detection of Pregnancy on earlier dates (before day-11 after Embrio transfer)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ernesto Bosch, MDPhD principal investigator
IVIRMA VALENCIA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pregnancy test in people with Pregnancy Test, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Early Detection of Pregnancy (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2020.