PregnancyPhase 4NCT01115140
Metformin and Folate in Pregnant Polycystic Ovary Syndrome(PCOS) Women
A Phase 4 study testing Metformin plus folic acid in people with Pregnancy and Polycystic Ovary Syndrome, run by University Magna Graecia at 1 site in Italy.
Trial summary
A more recent prospective nonrandomized placebo-controlled double-blind clinical study demonstrated that metformin exerts a slight but significant deleterious effect on serum homocysteine (Hcy) levels in patients with PCOS, and supplementation with folate is useful to increase the beneficial effect of metformin on the… Read more about this study
- Who is it for?
- Ages 18 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Polycystic Ovary Syndrome
- What is being tested?
- Metformin plus folic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2010to May 2011
- Phase
- Phase 4
- 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 38 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnancy
- PCOS
Who cannot join
- Risk factors for pregnancy complications
- Severe obesity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Metformin With or Without Folate Addiction on Uterine Blood Flow and Trophoblastic Invasion in Pregnant Patients With Polycystic Ovary Syndrome
A more recent prospective nonrandomized placebo-controlled double-blind clinical study demonstrated that metformin exerts a slight but significant deleterious effect on serum homocysteine (Hcy) levels in patients with PCOS, and supplementation with folate is useful to increase the beneficial effect of metformin on the vascular endothelium.
Read the detailed description
PCOS (cases) and non-PCOS (controls) pregnant women were enrolled. Cases will be randomized in four treatment groups: metformin plus placebo (group A1), metformin plus folic acid (group A2), placebo plus folic acid (group A3), placebo alone (group A4). Controls will not received any treatment (group B). Clinical and biochemical assessment (including serum markers of implantation), Doppler velocimetry of the uterine arteries, and trophoblastic invasion at histological and immunohistochemical evaluation.
Changes in clinical and biochemical data under treatment, pattern of Doppler velocimetry at the uterine arteries, and trophoblastic invasion were evaluated.
- Conditions
- Pregnancy, Polycystic Ovary Syndrome
- Being tested
- metformin plus placebo, Metformin plus folic acid, placebo plus folic acid, placebo alone
- Keywords
- Folate, Metformin, PCOS, Pregnancy, Trophoblastic invasion, Uterine artery velocimetry
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metformin plus placeboDrug
metformin 850 mg cp, 2 cps daily
Metformin plus folic acidDrug
metformin 850 mg cp, 2 cps daily plus folic acid 0.4 mg daily
placebo plus folic acidDrug
Placebo 1 cp daily plus folic acid 0.4 mg daily
placebo aloneDrug
placebo cp, 2 cps daily
| Study group | Role | What they receive |
|---|---|---|
| Group A1 | Active comparator | metformin plus placebo Receives: Drug: metformin plus placebo |
| Group A2 | Experimental | metformin plus folic acid Receives: Drug: Metformin plus folic acid |
| Group A3 | Active comparator | placebo plus folic acid Receives: Drug: placebo plus folic acid |
| Group A4 | Placebo comparator | placebo cp, 2 cps daily Receives: Drug: placebo alone |
| Group B | No intervention | observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trophoblastic invasion.
Istologic evaluation of trophoblastic ivasion,
Measured: two weeks
Secondary outcomes (1)
Doppler velocimetry measurements of the uterine artery.
Ultrasonographyc assessment of Doppler velocimetry measurements of the uterine artery.
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startMar 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Magna Graecia
- Sponsor type
- University, hospital or other
- Investigators
- Fulvio Zullo, MD, Study chair, Department of Obstetrics and Gynecology, University "Magna Graecia" of CatanzaroStefano Palomba, MD, Principal investigator, Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115140
- Sponsor's protocol ID
- 01/2010
- Status last verified
- May 2011
- First submitted
- 3 May 2010
- Last updated
- 24 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Metformin With or Without Folate Addiction on Uterine Blood Flow and Trophoblastic Invasion in Pregnant Patients With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT01115140
- Acronym / sponsor ID
- 01/2010
- Conditions
- Pregnancy, Polycystic Ovary Syndrome
- Keywords
- Folate, Metformin, PCOS, Pregnancy, Trophoblastic invasion, Uterine artery velocimetry
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Magna GraeciaUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 4 May 2010 (estimated)
- 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.
A more recent prospective nonrandomized placebo-controlled double-blind clinical study demonstrated that metformin exerts a slight but significant deleterious effect on serum homocysteine (Hcy) levels in patients with PCOS, and supplementation with folate is useful to increase the beneficial effect of metformin on the vascular endothelium.
Detailed description
PCOS (cases) and non-PCOS (controls) pregnant women were enrolled. Cases will be randomized in four treatment groups: metformin plus placebo (group A1), metformin plus folic acid (group A2), placebo plus folic acid (group A3), placebo alone (group A4). Controls will not received any treatment (group B). Clinical and biochemical assessment (including serum markers of implantation), Doppler velocimetry of the uterine arteries, and trophoblastic invasion at histological and immunohistochemical evaluation.
Changes in clinical and biochemical data under treatment, pattern of Doppler velocimetry at the uterine arteries, and trophoblastic invasion were evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A1 | Active comparator | Drug: metformin plus placebometformin plus placebo |
| Group A2 | Experimental | Drug: Metformin plus folic acidmetformin plus folic acid |
| Group A3 | Active comparator | Drug: placebo plus folic acidplacebo plus folic acid |
| Group A4 | Placebo comparator | Drug: placebo aloneplacebo cp, 2 cps daily |
| Group B | No intervention | –observation |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pregnancy
- PCOS
Key exclusion criteria (2 listed)
- Risk factors for pregnancy complications
- Severe obesity
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 plus placebometformin 850 mg cp, 2 cps daily | Drug | Group A1 |
| Metformin plus folic acidmetformin 850 mg cp, 2 cps daily plus folic acid 0.4 mg daily | Drug | Group A2 |
| placebo plus folic acidPlacebo 1 cp daily plus folic acid 0.4 mg daily | Drug | Group A3 |
| placebo aloneplacebo cp, 2 cps daily | Drug | Group A4 |
Primary outcome
Trophoblastic invasion.
Time frame: two weeks
Istologic evaluation of trophoblastic ivasion,
1 secondary outcome
Doppler velocimetry measurements of the uterine artery.
Time frame: two 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 24 May 2011.
Related trials for Pregnancy
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
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.
Fulvio Zullo, MD study chair
Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
Stefano Palomba, MD principal investigator
Department of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformin plus folic acid in people with Pregnancy and Polycystic Ovary Syndrome, run by University Magna Graecia at 1 site in Italy.
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 2 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 24 May 2011. 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 Italy. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Trophoblastic invasion. (time frame: two weeks). 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 24 May 2011.