Infertility, FemaleMINT-IINCT05780489
Evaluation of Salivary ELISA for Hormone Monitoring in Donors
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 2 sites in Spain.
Trial summary
In donors or patients undergoing assisted reproduction treatments (ART) it is necessary to closely control ovarian stimulation to monitor the number and size of developing follicles. Oestradiol (E2) and progesterone (P4) are products of steroidogenesis. Read more about this study
- Who is it for?
- Ages 18 to 35 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
- 200 participants
- Where
- 2 sitesSpain
- Study dates
- 14 Apr 2023to Dec 2024
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Informed consent form dated and signed
- Woman undergoing COS for oocyte donation
- Age 18-35, inclusive
- Regular menstrual cycles
- In good health and not suffering from any mental or medical condition(s) that would preclude participation in the study
Who cannot join
- Simultaneous participation in other clinical study, that at the investigator's criteria could interfere with the results of this study.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Ivi Madrid
Madrid, 28023
MONICA TORIBIO, +34 651 79 10 00, IVESMADRID@IVIRMA.COM
- Recruiting
IVI Valencia
Valencia, 46015
Ernesto Bosch, MDPhD, 963050900, ernesto.bosch@ivirma.com
Laura Caracena, Mrs, 963050925, laura.caracena@ivirma.com
About this study
In donors or patients undergoing assisted reproduction treatments (ART) it is necessary to closely control ovarian stimulation to monitor the number and size of developing follicles.
Oestradiol (E2) and progesterone (P4) are products of steroidogenesis. Their concentrations increase with the diameter of the growing follicle. In order to assess treatment response and support clinical decisions, accurate and reliable methods to measure E2 and P4 are essential. Measurement of both hormones, as well as monitoring of follicle growth through ultrasound measurements, is an important part of ovarian stimulation, requiring patients or donors to undergo multiple blood draws. It is often a physically and emotionally painful process, and the most convenient solution is the measurement of hormones concentrations in other biological fluids, such as saliva. Salivary diagnostic tests are a less invasive, inexpensive, and stress-free alternative.
The current study pretends to evaluate the correlation between salivary ELISA assays and serum determination of progesterone and oestradiol concentrations in oocyte donors, and, also, evaluate the feasibility of doing saliva E2 and P4 determinations in the IVIRMA clinic labs.
- Conditions
- Infertility, Female, Reproductive Sterility
- Being tested
- Determination of progesterone and oestradiol
- Keywords
- SALIVA, DONNORS, OESTRADIOL, PROGESTERONE
- 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 |
|---|---|---|
| DONORS UNDER CONTROLLED OVARIAN STIMULATION | Experimental | Saliva samples will be analyzed using oestradiol and progesterone ELISA kits. 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.
E2 and P4 on Day 1
Measurement of saliva E2 adn P4 values on day 1 stimulation
Measured: 1 YEAR
E2 and P4 on Day 8
Measurement of saliva E2 adn P4 values on day 8 of stimulation
Measured: 1 YEAR
E2 and P4 on Triggering day
Measurement of saliva E2 adn P4 values on triggering day
Measured: 1 YEAR
Secondary outcomes (3)
BODY MASS INDEX
Measurement of body mass index
Measured: 1 year
DONOR'S AGE
Age at the procedure moment
Measured: 1 year
NUMBER OF OOCYTES
Number of oocytes collected
Measured: 1 YEAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start14 Apr 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
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
- Model description
- This is a prospective multicentric study,
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
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
- NCT05780489
- Sponsor's protocol ID
- 2211-VLC-158-EB
- Acronym
- MINT-II
- Status last verified
- Mar 2024
- First submitted
- 28 Feb 2023
- Last updated
- 12 Mar 2024
- 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 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Salivary ELISA for Hormone Monitoring in Donors
- ClinicalTrials.gov ID
- NCT05780489
- Acronym / sponsor ID
- MINT-II / 2211-VLC-158-EB
- Conditions
- Infertility, Female, Reproductive Sterility
- Keywords
- SALIVA, DONNORS, OESTRADIOL, PROGESTERONE
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
- Collaborators
- MINT DIAGNOSTICS
- Study start
- 14 Apr 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 22 Mar 2023 (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 donors or patients undergoing assisted reproduction treatments (ART) it is necessary to closely control ovarian stimulation to monitor the number and size of developing follicles.
Oestradiol (E2) and progesterone (P4) are products of steroidogenesis. Their concentrations increase with the diameter of the growing follicle. In order to assess treatment response and support clinical decisions, accurate and reliable methods to measure E2 and P4 are essential. Measurement of both hormones, as well as monitoring of follicle growth through ultrasound measurements, is an important part of ovarian stimulation, requiring patients or donors to undergo multiple blood draws. It is often a physically and emotionally painful process, and the most convenient solution is the measurement of hormones concentrations in other biological fluids, such as saliva. Salivary diagnostic tests are a less invasive, inexpensive, and stress-free alternative.
The current study pretends to evaluate the correlation between salivary ELISA assays and serum determination of progesterone and oestradiol concentrations in oocyte donors, and, also, evaluate the feasibility of doing saliva E2 and P4 determinations in the IVIRMA clinic labs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective multicentric study,
| Arm | Type | Receives |
|---|---|---|
| DONORS UNDER CONTROLLED OVARIAN STIMULATION | Experimental | Diagnostic Test: Determination of progesterone and oestradiolSaliva samples will be analyzed using oestradiol and progesterone ELISA kits. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Informed consent form dated and signed
- Woman undergoing COS for oocyte donation
- Age 18-35, inclusive
- Regular menstrual cycles
- In good health and not suffering from any mental or medical condition(s) that would preclude participation in the study
Key exclusion criteria (1 listed)
- Simultaneous participation in other clinical study, that at the investigator's criteria could interfere with the results of this 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 | DONORS UNDER CONTROLLED OVARIAN STIMULATION |
Primary outcome
E2 and P4 on Day 1
Time frame: 1 YEAR
Measurement of saliva E2 adn P4 values on day 1 stimulation
E2 and P4 on Day 8
Time frame: 1 YEAR
Measurement of saliva E2 adn P4 values on day 8 of stimulation
E2 and P4 on Triggering day
Time frame: 1 YEAR
Measurement of saliva E2 adn P4 values on triggering day
3 secondary outcomes
BODY MASS INDEX
Time frame: 1 year
DONOR'S AGE
Time frame: 1 year
NUMBER OF OOCYTES
Time frame: 1 YEAR
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Infertility, Female
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingPhase 2
A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
Functional Hypothalamic Amenorrhea, FHA
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
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.
2 sites 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 2 sites 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: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
E2 and P4 on Day 1 (time frame: 1 YEAR). The study lists 3 primary outcomes in all. 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 Mar 2024.