Infertility, FemalePhase 2METINNCT06012682
Clinical Trials Evaluating the Effect of Metformin Treatment on Function Endometrium in Women Diagnosed With Idiopathic Infertility
A Phase 2 study testing Metformin Hydrochloride in people with Infertility, Female, run by Medical University of Bialystok.
Trial summary
Randomized, controlled, double-blind, three-arm clinical trial in which 75 women will be randomized to treatment with metformin, 75 women to treatment with placebo and 50 women to the observation group. The medical intervention will last 24 weeks (6 months). 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?
- Metformin Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2023to 30 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Age 18-45
- No pregnancy for a minimum of 12 months prior to screening.
- Diagnosed with idiopathic infertility.
- No use of hormone therapy 30 days before screening.
- No use of any methods of contraception 30 days before screening and during the examination.
- BMI between 18.5 - 30 kg/m2.
Who cannot join
- Positive pregnancy test result.
- Patients diagnosed with another factor of infertility.
- Patients with type I or II diabetes.
- Patients taking metformin or other hypoglycaemic drugs in the last 4 weeks before screening.
- Patients with hepatic impairment and abnormal liver function tests (alanine aminotransferase and/or aspartate aminotransferase (above 3x ULN).
- Patients with an eGFR less than 45 mL/min/1.73m2.
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- Accompanying chronic diseases with poor prognosis.
- Patients with a history of lactic acidosis or other metabolic acidosis.
- Patients with a history of congestive heart failure III/IV NYHA degree.
- Patients with acute myocardial ischemia.
- Patients with sepsis or severe infection.
- Diseases which, in the opinion of the investigator, constitute an exclusion criterion and prevent the patient from participating in the study.
- Patients with predictable problems with cooperation with the research team.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Monika Zbucka-Krętowska, Associate Professor contact
About this study
Official title: A Randomized, Controlled, Double-blind Study Clinical Trials Evaluating the Effect of Metformin Treatment on Function Endometrium in Women Diagnosed With Idiopathic Infertility
Randomized, controlled, double-blind, three-arm clinical trial in which 75 women will be randomized to treatment with metformin, 75 women to treatment with placebo and 50 women to the observation group. The medical intervention will last 24 weeks (6 months). Women with confirmed idiopathic infertility, in whom infertility factors have been excluded during full diagnostics, will be included in the study
- Conditions
- Infertility, Female
- Being tested
- Metformin Hydrochloride, Placebo
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin HydrochlorideDrug
The investigational medicinal product/placebo will be dispensed to study participants by study staff during randomization visits V1, V2, V3, V4, V5 and V6.
The randomized patient will receive the investigational medicinal product/placebo in tablets of 500 mg. The received tablets will be dispensed in an amount sufficient for the next visit. Patients will be asked to bring unused medicine and all empty ones packaging to the Center for each subsequent visit. The investigational medicinal product/placebo will be administered orally 500 mg three times a day (Table No. 1). The dose of the study product will be gradually increased from 500 mg/day to 1500 mg/day in order to avoid or reduce side effects related to taking the study medicinal product metformin
PlaceboDrug
The investigational medicinal product/placebo will be dispensed to study participants by study staff during randomization visits V1, V2, V3, V4, V5 and V6.
The randomized patient will receive the investigational medicinal product/placebo in tablets of 500 mg. The received tablets will be dispensed in an amount sufficient for the next visit. Patients will be asked to bring unused medicine and all empty ones packaging to the Center for each subsequent visit. The investigational medicinal product/placebo will be administered orally 500 mg three times a day (Table No. 1). The dose of the study product will be gradually increased from 500 mg/day to 1500 mg/day in order to avoid or reduce side effects related to taking the study medicinal product metformin
| Study group | Role | What they receive |
|---|---|---|
| metformin | Experimental | patients randomized to received metformin Receives: Drug: Metformin Hydrochloride |
| placebo | Placebo comparator | patients randomized to received placebo Receives: Drug: Placebo |
| group without intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of metformin on fertility and the possibility of becoming pregnant,as measured by pregnancy test strips and β-hCG levels
The aim of the study is to evaluate the effect of metformin on endometrial function in women diagnosed with idiopathic infertility, by proving the use of the proposed therapy to improve fertility in these women.
Measured: 4 years
Secondary outcomes (5)
Evaluation of the effect of metformin therapy on endometrial function.
It will be tested by assessing the concentration of biomarkers in the tissue before and after treatment
Measured: 4 years
Molecular analysis of endometrial tissues using Next Generation Sequencing (NGS) technology
Transcriptome analysis of endometrial tissues before and after metformin therapy.
Measured: 4 years
Intra-tissue metabolic profiling of steroids
The study will test whether treatment with metformin affects the intracrine production of steroid hormones in the endometrium.
Measured: 4 years
Oxidative stress evaluation by using total oxidative capacity (TOC) and total antioxidant capacity (TAC)
In-depth analysis of molecular and cellular processes using multi-omics combined with clinical data will provide essential knowledge about the mechanisms of metformin's action, which may have clinical applications not only in cases of idiopathic female infertility but also in other disorders.
Measured: 4 years
Quality of Life questionary evaluation SF-36, FertiQoL,
The results on the response scales are rotatable, summed and scaled from 0 to 100. Subscale and higher scores indicate good quality life. The number of obtained equation points is 50 or less arrangements with a psychologist.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start30 Aug 2023 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Bialystok
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Agency, Poland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012682
- Sponsor's protocol ID
- 2021/ABM/03/00006
- Acronym
- METIN
- Status last verified
- Aug 2023
- First submitted
- 22 Jun 2023
- Last updated
- 25 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Double-blind Study Clinical Trials Evaluating the Effect of Metformin Treatment on Function Endometrium in Women Diagnosed With Idiopathic Infertility
- ClinicalTrials.gov ID
- NCT06012682
- Acronym / sponsor ID
- METIN / 2021/ABM/03/00006
- Conditions
- Infertility, Female
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Medical University of BialystokUniversity, hospital or other
- Collaborators
- Medical Research Agency, Poland
- Study start
- 30 Aug 2023 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 25 Aug 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.
Randomized, controlled, double-blind, three-arm clinical trial in which 75 women will be randomized to treatment with metformin, 75 women to treatment with placebo and 50 women to the observation group. The medical intervention will last 24 weeks (6 months). Women with confirmed idiopathic infertility, in whom infertility factors have been excluded during full diagnostics, will be included in the study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| metformin | Experimental | Drug: Metformin Hydrochloridepatients randomized to received metformin |
| placebo | Placebo comparator | Drug: Placebopatients randomized to received placebo |
| group without intervention | No intervention | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18-45
- No pregnancy for a minimum of 12 months prior to screening.
- Diagnosed with idiopathic infertility.
- No use of hormone therapy 30 days before screening.
- No use of any methods of contraception 30 days before screening and during the examination.
Key exclusion criteria (13 listed)
- Positive pregnancy test result.
- Patients diagnosed with another factor of infertility.
- Patients with type I or II diabetes.
- Patients taking metformin or other hypoglycaemic drugs in the last 4 weeks before screening.
- Patients with hepatic impairment and abnormal liver function tests (alanine aminotransferase and/or aspartate aminotransferase (above 3x ULN).
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 |
|---|---|---|
| Metformin HydrochlorideThe investigational medicinal product/placebo will be dispensed to study participants by study staff during randomization visits V1, V2, V3, V4, V5 and V6. The randomized patient will receive the investigational medicinal product/placebo in tablets of 500 mg. The received tablets will be dispensed in an amount sufficient for the next visit. Patients will be asked to bring unused medicine and all empty ones packaging to the Center for each subsequent visit. The investigational medicinal product/placebo will be administered orally 500 mg three times a day (Table No. 1). The dose of the study product will be gradually increased from 500 mg/day to 1500 mg/day in order to avoid or reduce side effects related to taking the study medicinal product metformin | Drug | metformin |
| PlaceboThe investigational medicinal product/placebo will be dispensed to study participants by study staff during randomization visits V1, V2, V3, V4, V5 and V6. The randomized patient will receive the investigational medicinal product/placebo in tablets of 500 mg. The received tablets will be dispensed in an amount sufficient for the next visit. Patients will be asked to bring unused medicine and all empty ones packaging to the Center for each subsequent visit. The investigational medicinal product/placebo will be administered orally 500 mg three times a day (Table No. 1). The dose of the study product will be gradually increased from 500 mg/day to 1500 mg/day in order to avoid or reduce side effects related to taking the study medicinal product metformin | Drug | placebo |
Primary outcome
Effects of metformin on fertility and the possibility of becoming pregnant,as measured by pregnancy test strips and β-hCG levels
Time frame: 4 years
The aim of the study is to evaluate the effect of metformin on endometrial function in women diagnosed with idiopathic infertility, by proving the use of the proposed therapy to improve fertility in these women.
5 secondary outcomes
Evaluation of the effect of metformin therapy on endometrial function.
Time frame: 4 years
Molecular analysis of endometrial tissues using Next Generation Sequencing (NGS) technology
Time frame: 4 years
Intra-tissue metabolic profiling of steroids
Time frame: 4 years
Oxidative stress evaluation by using total oxidative capacity (TOC) and total antioxidant capacity (TAC)
Time frame: 4 years
Quality of Life questionary evaluation SF-36, FertiQoL,
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
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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.
Monika Zbucka-Krętowska, Associate Professor contact
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin Hydrochloride in people with Infertility, Female, run by Medical University of Bialystok.
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 6 inclusion and 13 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: opening soon, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monika Zbucka-Krętowska, Associate Professor (+48 85 831 87 89, monika.zbucka-kretowska@umb.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of metformin on fertility and the possibility of becoming pregnant,as measured by pregnancy test strips and β-hCG levels (time frame: 4 years). 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 25 Aug 2023.