Infertility, FemaleNCT03725904
Daytime Profile of Salivary Progesterone
A study testing Progesterone analysis in saliva in people with Infertility, Female, run by Peter Humaidan at 1 site in Denmark.
Trial summary
The aim of this study is to perform a 12-hour profile of free saliva progesterone during the luteal phase after fresh and frozen embryo transfer. If progesterone levels in saliva samples show a constant level during daytime, this non-invasive measurement can be used in future ART patients with insufficient… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Progesterone analysis in saliva
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 24 Oct 2018to 1 Jan 2020
- Phase
- Interventional
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-45 years
- One or two good quality embryos for transfer on day 5.
- BMI >18,5 <30 kg/m²
Who cannot join
- No good quality embryos for transfer
- Uterine abnormalities
- One ovary
- Oocyte donation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Daytime Profile of Salivary Progesterone During the Mid-luteal Phase of IVF and FET Cycles
The aim of this study is to perform a 12-hour profile of free saliva progesterone during the luteal phase after fresh and frozen embryo transfer. If progesterone levels in saliva samples show a constant level during daytime, this non-invasive measurement can be used in future ART patients with insufficient progesterone levels who might benefit from additional exogenous progesterone supplementation.
- Conditions
- Infertility, Female
- Being tested
- Progesterone analysis in saliva
- Keywords
- Progesterone, Saliva, IVF, Frozen embryo transfer
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progesterone analysis in salivaDiagnostic test
Analysis of salava progesterone
| Study group | Role | What they receive |
|---|---|---|
| IVF/FET | Experimental | Not described Receives: Diagnostic Test: Progesterone analysis in saliva |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of free progesterone in saliva
Measured: 12 hours
Secondary outcomes (2)
Clinical pregnancy rate
Ultrasound detected gestational sack divided with number of embryo transfer
Measured: 8 weeks
Ongoing pregnancy rate
Viable pregnancy after gestational week 12+0
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start24 Oct 2018
- Primary completion3 Apr 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies 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
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter Humaidan
- Sponsor type
- University, hospital or other
- Collaborators
- Boston IVF
- Responsible party
- Sponsor-investigator, Peter Humaidan, Regionshospitalet Viborg, Skive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03725904
- Sponsor's protocol ID
- Saliva1
- Status last verified
- Oct 2018
- First submitted
- 26 Oct 2018
- Last updated
- 22 Jan 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 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daytime Profile of Salivary Progesterone During the Mid-luteal Phase of IVF and FET Cycles
- ClinicalTrials.gov ID
- NCT03725904
- Acronym / sponsor ID
- Saliva1
- Conditions
- Infertility, Female
- Keywords
- Progesterone, Saliva, IVF, Frozen embryo transfer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Peter HumaidanUniversity, hospital or other
- Collaborators
- Boston IVF
- Study start
- 24 Oct 2018 (actual)
- Primary completion
- 3 Apr 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 31 Oct 2018 (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.
The aim of this study is to perform a 12-hour profile of free saliva progesterone during the luteal phase after fresh and frozen embryo transfer. If progesterone levels in saliva samples show a constant level during daytime, this non-invasive measurement can be used in future ART patients with insufficient progesterone levels who might benefit from additional exogenous progesterone supplementation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IVF/FET | Experimental | Diagnostic Test: Progesterone analysis in saliva |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-45 years
- One or two good quality embryos for transfer on day 5.
- BMI >18,5 <30 kg/m²
Key exclusion criteria (4 listed)
- No good quality embryos for transfer
- Uterine abnormalities
- One ovary
- Oocyte donation
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 |
|---|---|---|
| Progesterone analysis in salivaAnalysis of salava progesterone | Diagnostic test | IVF/FET |
Primary outcome
Levels of free progesterone in saliva
Time frame: 12 hours
2 secondary outcomes
Clinical pregnancy rate
Time frame: 8 weeks
Ongoing pregnancy rate
Time frame: 12 weeks
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 22 Jan 2020.
- 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.
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?
A study testing Progesterone analysis in saliva in people with Infertility, Female, run by Peter Humaidan at 1 site in Denmark.
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 3 inclusion and 4 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 22 Jan 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 Denmark. 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?
Levels of free progesterone in saliva (time frame: 12 hours). 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 22 Jan 2020.