InfertilityNCT03162809
Needle-Free Monitoring for IVF Patient Cycles
An observational study of Infertility, run by Boston IVF at 1 site in United States.
Trial summary
Salivary diagnostic testing is emerging as a less invasive, inexpensive alternative to serum analyte measurements with proven diagnostic accuracy in clinical settings. This study aims to continue analyzing aspects of the performance of salivary hormone competitive immunoassays for monitoring patient's reproductive… Read more about this study
- Who is it for?
- Ages 25 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2017to Jun 2021
- 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 25 to 43 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients undergoing In Vitro Fertilization (IVF) at a participating infertility center
Who may be able to join
- Diagnosis of infertility.
- Cycle start age of 25 -43 years.
- Undergoing controlled ovarian stimulation for IVF.
- All monitoring scheduled at the participating IVF facility.
Who cannot join
- -Prior cancelled cycle due to hyperstimulation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Venopuncture-Free Monitoring During IVF: Are More Frequent Sequential Salivary Hormone Measurements More Informative Than Daily Serum Monitoring of IVF Patients?
Salivary diagnostic testing is emerging as a less invasive, inexpensive alternative to serum analyte measurements with proven diagnostic accuracy in clinical settings. This study aims to continue analyzing aspects of the performance of salivary hormone competitive immunoassays for monitoring patient's reproductive hormone profiles in the reproductive cycle. Hormone levels will be monitored during treatment cycles for infertility.
Read the detailed description
This study will be a prospective study to measure salivary and serum estrogen and progesterone levels in subject's voluntarily undergoing monitored infertility treatment cycles including controlled ovarian stimulation (COS) with oral agents or gonadotropins and controlled ovarian hyperstimulation (COH) for in vitro fertilization (IVF). Ultimately, the potential applicability and reliability of salivary steroid monitoring in IVF cycles will be assessed.
- Conditions
- Infertility
- Keywords
- infertility, in vitro fertilization, Estradiol, Progesterone
- Medical subject headings
- Infertility
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of multiple Progesterone levels as an aid during an IVF cycle
To determine if collecting multiple salivary Progesterone levels versus a single serum hormone sample could assist in predicting the administration of Human Chorionic Gonadotropin (HCG) during an IVF cycle.
Measured: 1 month
Secondary outcomes (2)
Measurement of salivary Estradiol level as an aid during fertility treatment
Comparison of salivary reproductive hormone values versus serum collection to see if there is a correlation between the two methods of collection.
Measured: 1 month
Measurement of salivary Progesterone level as an aid during fertility treatment
Comparison of salivary reproductive hormone values versus serum collection to see if there is a correlation between the two methods of collection.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start9 May 2017
- Primary completionApr 2021 (estimated)
- Study completionJun 2021 (estimated)
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston IVF
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denny Sakkas, PhD, Principal investigator, Boston IVF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03162809
- Sponsor's protocol ID
- SAL201702
- Status last verified
- Aug 2020
- First submitted
- 11 Apr 2017
- Last updated
- 12 Aug 2020
- Results posted
- No
- 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 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venopuncture-Free Monitoring During IVF: Are More Frequent Sequential Salivary Hormone Measurements More Informative Than Daily Serum Monitoring of IVF Patients?
- ClinicalTrials.gov ID
- NCT03162809
- Acronym / sponsor ID
- SAL201702
- Conditions
- Infertility
- Keywords
- infertility, in vitro fertilization, Estradiol, Progesterone
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Boston IVFUniversity, hospital or other
- Study start
- 9 May 2017 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 22 May 2017 (actual)
- 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.
Salivary diagnostic testing is emerging as a less invasive, inexpensive alternative to serum analyte measurements with proven diagnostic accuracy in clinical settings. This study aims to continue analyzing aspects of the performance of salivary hormone competitive immunoassays for monitoring patient's reproductive hormone profiles in the reproductive cycle. Hormone levels will be monitored during treatment cycles for infertility.
Detailed description
This study will be a prospective study to measure salivary and serum estrogen and progesterone levels in subject's voluntarily undergoing monitored infertility treatment cycles including controlled ovarian stimulation (COS) with oral agents or gonadotropins and controlled ovarian hyperstimulation (COH) for in vitro fertilization (IVF). Ultimately, the potential applicability and reliability of salivary steroid monitoring in IVF cycles will be assessed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients undergoing In Vitro Fertilization (IVF) at a participating infertility center
Key inclusion criteria (4 listed)
- Diagnosis of infertility.
- Cycle start age of 25 -43 years.
- Undergoing controlled ovarian stimulation for IVF.
- All monitoring scheduled at the participating IVF facility.
Key exclusion criteria (1 listed)
- -Prior cancelled cycle due to hyperstimulation.
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
Measurement of multiple Progesterone levels as an aid during an IVF cycle
Time frame: 1 month
To determine if collecting multiple salivary Progesterone levels versus a single serum hormone sample could assist in predicting the administration of Human Chorionic Gonadotropin (HCG) during an IVF cycle.
2 secondary outcomes
Measurement of salivary Estradiol level as an aid during fertility treatment
Time frame: 1 month
Measurement of salivary Progesterone level as an aid during fertility treatment
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
- Individual participant dataSharing planned: No
Related trials for Infertility
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
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.
Denny Sakkas, PhD principal investigator
Boston IVF
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 Boston IVF 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 4 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: status not confirmed, as of the sponsor's last update on 12 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 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?
Results are not available in the source record.
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?
Measurement of multiple Progesterone levels as an aid during an IVF cycle (time frame: 1 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 12 Aug 2020.