Infertility, FemaleSALIVA_MINTNCT05184777
Evaluation of Salivary ELISA for Hormone Monitoring in IVF Patients
A study testing Determination of progesterone and oestradiol in people with Infertility, Female and Reproductive Sterility, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
Trial summary
In assisted reproductive treatment (ART), it is necessary to follow closely the stimulation cycles of patients undergoing these treatments in order to monitor the number and size of developing follicles. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Infertility, Female, Reproductive Sterility
- What is being tested?
- Determination of progesterone and oestradiol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 3 Feb 2022to 20 Feb 2023
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Patients undergoing IVF/ICSI treatment
- Patients planned to embryo transfer (ET) undergoing hormonal replacement therapy
- Aged from18-45 years old.
- BMI 19-30 kg/m2
- Signed written informed consent
Who cannot join
- Patients suffering for any systemic disease or endocrine disorder will be excluded foe the study
Trial locations and contacts
1 site in 1 country.
About this study
In assisted reproductive treatment (ART), it is necessary to follow closely the stimulation cycles of patients undergoing these treatments in order to monitor the number and size of developing follicles. Oestradiol (E2) and progesterone (P) are products of steroidogenesis and the concentrations of both hormones increase with the diameter of the growing follicle and accurate and reliable methods to measure E2 and P are essential to assess treatment response and support clinical decision. Measurement of both hormones, as well as monitoring of follicle growth through ultrasound measurements, is an important part of ovarian stimulation, requiring patients to undergo multiple blood draws. It is often a physically and emotionally painful process and the most convenient solution to this problem is the measurement of hormone concentration in other biological fluids. Salivary diagnostic tests are a less invasive, inexpensive and stress-free alternative to measurements of hormone concentration in other biological fluids. The current study pretends to evaluate the correlation between salivary ELISA assays and serum determination of progesterone and oestradiol concentrations IVF patients. In addition, secondary objectives include the measurement of diurnal variability of salivary hormone levels and patient experience with saliva collection as users.
- Conditions
- Infertility, Female, Reproductive Sterility
- Being tested
- Determination of progesterone and oestradiol
- Keywords
- ELISA, Saliva, Progesterone, Oestradiol, Early follicular phase, Mild follicular phase, Late follicular phase
- Medical subject headings
- Infertility, Female, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determination of progesterone and oestradiolDiagnostic test
Blood and saliva samples will be taken for determination of progesterone and oestradiol hormones.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing ovarian stimulation for IVF/ICSI | Experimental | 90 patients undergoing ovarian stimulation for IVF/ICSI; Low, average and high responders will be included in equal proportions, in order to cover the widest range of hormonal values (30 blood and saliva samples per ovarian stimulation point will be taken for determination of progesterone and oestradiol). Receives: Diagnostic Test: Determination of progesterone and oestradiol |
| Patients for embryo transfer (ET) undergoing hormonal replacement therapy | Experimental | 30 patients for embryo transfer (ET) undergoing hormonal replacement therapy. These patients will only have a progesterone determination in their blood and saliva samples on the day of ET. Receives: Diagnostic Test: Determination of progesterone and oestradiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the correlation between salivary ELISA assays and serum determination of progesterone and oestradiol concentrations IVF patients.
between salivary ELISA assays and serum determination of progesterone and oestradiol concentrations
Measured: 12 months
Secondary outcomes (2)
Diurnal variability of salivary progesterone and oestradiol levels
Measurement of progesterone and oestradiol levels
Measured: 12 months
Patient User Experience with saliva collection
Registry of patient experience with saliva collection as users using a specific questionary. (Yes/No question)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start3 Feb 2022
- Primary completion17 May 2022
- Study completion20 Feb 2023
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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective unicentric study
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Sponsor type
- University, hospital or other
- Collaborators
- MINT DIAGNOSTICS
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05184777
- Sponsor's protocol ID
- 2107-VLC-071-EB
- Acronym
- SALIVA_MINT
- Status last verified
- Feb 2023
- First submitted
- 22 Dec 2021
- Last updated
- 1 Mar 2023
- 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 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Salivary ELISA for Hormone Monitoring in IVF Patients
- ClinicalTrials.gov ID
- NCT05184777
- Acronym / sponsor ID
- SALIVA_MINT / 2107-VLC-071-EB
- Conditions
- Infertility, Female, Reproductive Sterility
- Keywords
- ELISA, Saliva, Progesterone, Oestradiol, Early follicular phase, Mild follicular phase, Late follicular phase
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
- Collaborators
- MINT DIAGNOSTICS
- Study start
- 3 Feb 2022 (actual)
- Primary completion
- 17 May 2022 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 11 Jan 2022 (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.
In assisted reproductive treatment (ART), it is necessary to follow closely the stimulation cycles of patients undergoing these treatments in order to monitor the number and size of developing follicles. Oestradiol (E2) and progesterone (P) are products of steroidogenesis and the concentrations of both hormones increase with the diameter of the growing follicle and accurate and reliable methods to measure E2 and P are essential to assess treatment response and support clinical decision. Measurement of both hormones, as well as monitoring of follicle growth through ultrasound measurements, is an important part of ovarian stimulation, requiring patients to undergo multiple blood draws. It is often a physically and emotionally painful process and the most convenient solution to this problem is the measurement of hormone concentration in other biological fluids. Salivary diagnostic tests are a less invasive, inexpensive and stress-free alternative to measurements of hormone concentration in other biological fluids. The current study pretends to evaluate the correlation between salivary ELISA assays and serum determination of progesterone and oestradiol concentrations IVF patients. In addition, secondary objectives include the measurement of diurnal variability of salivary hormone levels and patient experience with saliva collection as users.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective unicentric study
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing ovarian stimulation for IVF/ICSI | Experimental | Diagnostic Test: Determination of progesterone and oestradiol90 patients undergoing ovarian stimulation for IVF/ICSI; Low, average and high responders will be included in equal proportions, in order to cover the widest range of hormonal values (30 blood and saliva samples per ovarian stimulation point will be taken for determination of progesterone and oestradiol). |
| Patients for embryo transfer (ET) undergoing hormonal replacement therapy | Experimental | Diagnostic Test: Determination of progesterone and oestradiol30 patients for embryo transfer (ET) undergoing hormonal replacement therapy. These patients will only have a progesterone determination in their blood and saliva samples on the day of ET. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients undergoing IVF/ICSI treatment
- Patients planned to embryo transfer (ET) undergoing hormonal replacement therapy
- Aged from18-45 years old.
- BMI 19-30 kg/m2
- Signed written informed consent
Key exclusion criteria (1 listed)
- Patients suffering for any systemic disease or endocrine disorder will be excluded foe the study
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 |
|---|---|---|
| Determination of progesterone and oestradiolBlood and saliva samples will be taken for determination of progesterone and oestradiol hormones. | Diagnostic test | Patients for embryo transfer (ET) undergoing hormonal replacement therapy, Patients undergoing ovarian stimulation for IVF/ICSI |
Primary outcome
To evaluate the correlation between salivary ELISA assays and serum determination of progesterone and oestradiol concentrations IVF patients.
Time frame: 12 months
between salivary ELISA assays and serum determination of progesterone and oestradiol concentrations
2 secondary outcomes
Diurnal variability of salivary progesterone and oestradiol levels
Time frame: 12 months
Patient User Experience with saliva collection
Time frame: 12 months
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 1 Mar 2023.
- 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 Determination of progesterone and oestradiol in people with Infertility, Female and Reproductive Sterility, 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 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 1 Mar 2023. 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?
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?
To evaluate the correlation between salivary ELISA assays and serum determination of progesterone and oestradiol concentrations IVF patients. (time frame: 12 months). 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 1 Mar 2023.