Polycystic Ovary SyndromeEarly Phase 1MIPNCT02498522
Effect of Metformin on Early Pregnancy Loss in Pregnant Women With Polycystic Ovarian Syndrome
A Early Phase 1 study testing Metformin in people with Polycystic Ovary Syndrome, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this work is to study the effect of metformin use for reducing early pregnancy loss in pregnant patients with Polycystic ovary syndrome (PCOS). Read more about this study
- Who is it for?
- Ages 25 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Metformin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 166 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2015to Mar 2016
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age : 25 - 35.
- Pregnant patients in their 1st trimester with history of infertility due to PCOS confirmed by at least 2 of the following criteria ( Rotterdam Criteria )
- At least twelve small follicles 2-9 mm in at least one ovary; diagnosed by ultra sound examination.
- Symptoms or biochemical evidence of hyperandrogenism; diagnosed by examination and laboratory investigations.
- Anovulation or oligo-ovulation with fewer than nine menstrual periods every 12 months : diagnosed by thorough history taking.
- Non diabetic patients who received metformin along with other ovulation-inducing drugs prior to pregnancy.
Who cannot join
- patients with other causes of infertility other than PCOS
- contraindications to metformin : liver impairment , renal failure.
- Patients with PCOS who didn't receive Metformin with drugs of induction of ovulation before pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this work is to study the effect of metformin use for reducing early pregnancy loss in pregnant patients with Polycystic ovary syndrome (PCOS).
Read the detailed description
Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age. PCOS produces symptoms in approximately 5 to 10% of women of reproductive age (12-45 years old) and is thought to be one of the leading causes of the female subfertility
- The aim of this work is to study the effect of metformin use for reducing early pregnancy loss in pregnant patients with PCOS
- Research question:
In pregnant women with PCOS, does metformin use decreases the rate of early pregnancy loss?
-Research hypothesis: In Pregnant women with PCOS, metformin may reduce the rate of early pregnancy loss.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Metformin
- 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.
MetforminDrug
Also called cidophage
83 patients will continue metformin until end of 1st trimester
| Study group | Role | What they receive |
|---|---|---|
| metformin arm | Experimental | 83 patients will continue metformin until end of 1st trimester (14 weeks gestation) Receives: Drug: Metformin |
| control arm | Placebo comparator | 83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation) Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Miscarriage Rate
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionFeb 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Dabbous, Ain Shams University
- Investigators
- Ahmed M kotb, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02498522
- Sponsor's protocol ID
- Metformin in pregnancy
- Acronym
- MIP
- Status last verified
- Apr 2016
- First submitted
- 13 Jul 2015
- Last updated
- 19 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Metformin on Early Pregnancy Loss in Pregnant Women With Polycystic Ovarian Syndrome
- ClinicalTrials.gov ID
- NCT02498522
- Acronym / sponsor ID
- MIP / Metformin in pregnancy
- Conditions
- Polycystic Ovary Syndrome
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 15 Jul 2015 (estimated)
- Results
- Posted 19 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this work is to study the effect of metformin use for reducing early pregnancy loss in pregnant patients with Polycystic ovary syndrome (PCOS).
Detailed description
Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age. PCOS produces symptoms in approximately 5 to 10% of women of reproductive age (12-45 years old) and is thought to be one of the leading causes of the female subfertility
- The aim of this work is to study the effect of metformin use for reducing early pregnancy loss in pregnant patients with PCOS
- Research question:
In pregnant women with PCOS, does metformin use decreases the rate of early pregnancy loss?
-Research hypothesis: In Pregnant women with PCOS, metformin may reduce the rate of early pregnancy loss.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| metformin arm | Experimental | Drug: Metformin83 patients will continue metformin until end of 1st trimester (14 weeks gestation) |
| control arm | Placebo comparator | Drug: Metformin83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation) |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age : 25 - 35.
- Pregnant patients in their 1st trimester with history of infertility due to PCOS confirmed by at least 2 of the following criteria ( Rotterdam Criteria )
- Non diabetic patients who received metformin along with other ovulation-inducing drugs prior to pregnancy.
Key exclusion criteria (3 listed)
- patients with other causes of infertility other than PCOS
- contraindications to metformin : liver impairment , renal failure.
- Patients with PCOS who didn't receive Metformin with drugs of induction of ovulation before pregnancy.
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 |
|---|---|---|
| MetforminAlso: cidophage83 patients will continue metformin until end of 1st trimester | Drug | control arm, metformin arm |
Primary outcome
Miscarriage Rate
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ahmed M kotb, MD principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Metformin in people with Polycystic Ovary Syndrome, run by Ain Shams University at 1 site in Egypt.
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 3 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 19 May 2016. 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 Egypt. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Miscarriage Rate (time frame: 6 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 19 May 2016.