ProteomeNCT06804174
Comparison of Endometrial Protein Profile in Spontaneous Versus Stimulated Menstrual Cycles in Poor Responders
A study testing use of gonadotropins in people with Proteome, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
Evaluation of endometrial protein profile in spontaneous and stimulated menstrual cycles Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Proteome
- What is being tested?
- use of gonadotropins
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Sep 2023to 1 Sep 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 43 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Primary infertility
- Poor ovarian response
Who cannot join
- Normal or high ovarian response to gonadotropin stimulation
- Menstrual cycle disorders
- Severe male cause of infertility
- Preimplantation genetic testing
- Pathological findings of the uterus (fibroids, endometrial polyps, adenomyosis) and fallopian tubes (distal occlusion of one or both fallopian tubes with hydrosalpinx).
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
Division of Obstetrics and Gynecology, university Medical Centre Ljubljana
Ljubljana, 1000
About this study
Official title: Distinct Endometrial Protein Profiles in Spontaneous and Stimulated Cycles in Women With Poor Ovarian Respons
Evaluation of endometrial protein profile in spontaneous and stimulated menstrual cycles
- Conditions
- Proteome
- Being tested
- use of gonadotropins
- Keywords
- endometrium, proteome, poor ovarian response, spontaneous cycle, stimulated cycle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use of gonadotropinsOther
Comparison of endometrial proteome during the window of implantation between stimulated and spontaneous cycles.
| Study group | Role | What they receive |
|---|---|---|
| Poor responder women as per POSEIDON criteria | Experimental | Not described Receives: Other: use of gonadotropins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of endometrial proteome after the use of gonadotropins
Comparison of endometrial proteome during the window of implantation between spontaneous and stimulated cycles.
Measured: From enrollment to the end of treatment (approximately 2 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start1 Sep 2023
- Primary completion30 Jun 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ProteomeStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- Slovenian Research Agency (ARRS)
- Responsible party
- Sponsor
- Investigators
- Eda Prof. Vrtačnik bokal, MD, PhD, Study chair, Division of Obstetrics and Gynecology, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804174
- Sponsor's protocol ID
- (0120-319/2021/3)
- Status last verified
- Oct 2024
- First submitted
- 27 Jan 2025
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Abdulkhalikova D, Ban Frangez H, Burnik Papler T, Stimpfel M, Vrtacnik Bokal E, Salamun V. Distinct endometrial protein profiles in spontaneous and stimulated cycles in women with poor ovarian response: A prospective case-crossover clinical trial. PLoS One. 2026 May 19;21(5):e0338812. doi: 10.1371/journal.pone.0338812. eCollection 2026.
PubMed 42154768
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distinct Endometrial Protein Profiles in Spontaneous and Stimulated Cycles in Women With Poor Ovarian Respons
- ClinicalTrials.gov ID
- NCT06804174
- Acronym / sponsor ID
- (0120-319/2021/3)
- Conditions
- Proteome
- Keywords
- endometrium, proteome, poor ovarian response, spontaneous cycle, stimulated cycle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Collaborators
- Slovenian Research Agency (ARRS)
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 3 Feb 2025 (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.
Evaluation of endometrial protein profile in spontaneous and stimulated menstrual cycles
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Poor responder women as per POSEIDON criteria | Experimental | Other: use of gonadotropins |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Primary infertility
- Poor ovarian response
Key exclusion criteria (5 listed)
- Normal or high ovarian response to gonadotropin stimulation
- Menstrual cycle disorders
- Severe male cause of infertility
- Preimplantation genetic testing
- Pathological findings of the uterus (fibroids, endometrial polyps, adenomyosis) and fallopian tubes (distal occlusion of one or both fallopian tubes with hydrosalpinx).
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 |
|---|---|---|
| use of gonadotropinsComparison of endometrial proteome during the window of implantation between stimulated and spontaneous cycles. | Other | Poor responder women as per POSEIDON criteria |
Primary outcome
Analysis of endometrial proteome after the use of gonadotropins
Time frame: From enrollment to the end of treatment (approximately 2 months).
Comparison of endometrial proteome during the window of implantation between spontaneous and stimulated cycles.
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 3 Feb 2025.
- Derived from this study: PubMed 42154768Abdulkhalikova D, Ban Frangez H, Burnik Papler T, Stimpfel M, Vrtacnik Bokal E, Salamun V. Distinct endometrial protein profiles in spontaneous and stimulated cycles in women with poor ovarian response: A prospective case-crossover clinical trial. PLoS One. 2026 May 19;21(5):e0338812. doi: 10.1371/journal.pone.0338812. eCollection 2026.
- Individual participant dataSharing planned: Undecided
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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.
Eda Prof. Vrtačnik bokal, MD, PhD study chair
Division of Obstetrics and Gynecology, University Medical Centre Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing use of gonadotropins in people with Proteome, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 2 inclusion and 5 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 3 Feb 2025. 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 Slovenia. 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?
Analysis of endometrial proteome after the use of gonadotropins (time frame: From enrollment to the end of treatment (approximately 2 months).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06804174, which also lists 1 linked publication.
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 3 Feb 2025.