InfertilityNCT01184469
Prospective Observational Study of Peri-implantation Serum hCG Levels
An observational study of Infertility, run by Bruce Shapiro M.D. at 1 site in United States.
Trial summary
The purpose of this study is to prospectively define a set of data suitable for developing models of pregnancy viability. Those models will be based on serum hCG concentration measured during the peri-implantation period in patients that received fresh embryo transfer and those that received transfer of frozen-thawed… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- How many people
- 451 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to May 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: IVF patients
Who may be able to join
- IVF patients (adults) who received blastocyst transfer
Who cannot join
- Those patients using different laboratories
Trial locations and contacts
1 site in 1 country.
United States1 site
Fertility Center of Las Vegas
Las Vegas, Nevada, 89117
About this study
The purpose of this study is to prospectively define a set of data suitable for developing models of pregnancy viability. Those models will be based on serum hCG concentration measured during the peri-implantation period in patients that received fresh embryo transfer and those that received transfer of frozen-thawed embryos, and to compare and contrast these models. This may reveal insights into differences between these types of IVF cycles.
Read the detailed description
The current study seeks to examine the effect of the timing of implantation (as indicated by the first increase in serum hCG level) on the viability of pregnancies and to determine if such effect of timing differs between fresh embryo transfers and frozen-thawed embryos transfers. In this case, the timing of implantation will be measured through serum hCG analysis on days 3, 4, 5, and 7 after blastocyst transfer.
- Conditions
- Infertility
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Fresh embryo transfers | Patients who received fresh blastocyst transfer | |
| Thawed embryo transfers | Patients who received transfers of frozen/thawed embryos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy
Fetal heart motion at 10 weeks gestation.
Measured: 10 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionMar 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 451 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bruce Shapiro M.D.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Bruce Shapiro M.D., Fertility Center of Las Vegas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01184469
- Sponsor's protocol ID
- SAIRB 10-0007
- Status last verified
- Oct 2012
- First submitted
- 17 Aug 2010
- Last updated
- 15 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study of Peri-implantation Serum hCG Levels
- ClinicalTrials.gov ID
- NCT01184469
- Acronym / sponsor ID
- SAIRB 10-0007
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 451 participants (actual)
- Lead sponsor
- Bruce Shapiro M.D.Industry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 19 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to prospectively define a set of data suitable for developing models of pregnancy viability. Those models will be based on serum hCG concentration measured during the peri-implantation period in patients that received fresh embryo transfer and those that received transfer of frozen-thawed embryos, and to compare and contrast these models. This may reveal insights into differences between these types of IVF cycles.
Detailed description
The current study seeks to examine the effect of the timing of implantation (as indicated by the first increase in serum hCG level) on the viability of pregnancies and to determine if such effect of timing differs between fresh embryo transfers and frozen-thawed embryos transfers. In this case, the timing of implantation will be measured through serum hCG analysis on days 3, 4, 5, and 7 after blastocyst transfer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fresh embryo transfers | – | –Patients who received fresh blastocyst transfer |
| Thawed embryo transfers | – | –Patients who received transfers of frozen/thawed embryos |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- IVF patients
Key inclusion criteria (1 listed)
- IVF patients (adults) who received blastocyst transfer
Key exclusion criteria (1 listed)
- Those patients using different laboratories
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ongoing pregnancy
Time frame: 10 weeks gestation
Fetal heart motion at 10 weeks gestation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Bruce Shapiro M.D. at 1 site in United States.
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 1 inclusion and 1 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 15 Oct 2012. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ongoing pregnancy (time frame: 10 weeks gestation). 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 15 Oct 2012.