Polycystic Ovary SyndromePhase 4PCOSMICNCT00795808
PCOSMIC Trial - PolyCystic Ovary Syndrome, Metformin for Infertility With Clomiphene
A Phase 4 study testing Metformin, Metformin + Clomiphene and Clomiphene in people with Polycystic Ovary Syndrome, run by University of Auckland, New Zealand at 1 site in New Zealand.
Trial summary
1. Metformin increases the pregnancy rate when added to the standard treatment of anovulatory polycystic ovary syndrome (PCOS). 2. Metformin in combination with clomiphene, is more effective than clomiphene alone or metformin alone improves fertility outcomes in women with PCOS of reasonably healthy body weight (BMI… Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Metformin, Metformin + Clomiphene and Clomiphene
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 171 participants
- Where
- 1 siteNew Zealand
- Study dates
- Aug 2003to Oct 2008
- 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 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women between the age of 18 and 39 years inclusive.
- Anovulatory infertility of duration at least 12 months.
- Polycystic ovary syndrome, based on Rotterdam consensus criteria.
- Normal serum prolactin, thyroid function and 17-hydroxyprogesterone.
- Normal serum prolactin, thyroid function and 17-hydroxyprogesterone;
Who cannot join
- Presence of any other significant infertility factor including male factor, known tubal disease or history of an ectopic pregnancy, known endometriosis affecting the fallopian tubes or ovaries.
- Already taking oral hypoglycaemics.
- Diabetics receiving treatment.
- Renal impairment
- Chronic hepatic disease
- Cardiac Disease
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- Alcohol dependency
- Pre-disposition to lactic acidosis
- Previous ovarian drilling procedure, gonadotrophin injection therapy, IUI (intrauterine insemination) or IVF ( in vitro fertilisation).
- For those women who have had previous fertility treatment, the following would be excluded:
- Women who have had > 5 cycles of clomiphene citrate
- Women who have had > 5 months metformin treatment previously
- Women who have proven to be resistant to 100mg or more of clomiphene citrate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-Centre Randomised Controlled Trial of the Effectiveness of Metformin and Clomiphene Citrate for Treating Anovulatory Infertility in Women With Polycystic Ovary Syndrome
- Metformin increases the pregnancy rate when added to the standard treatment of anovulatory polycystic ovary syndrome (PCOS).
- Metformin in combination with clomiphene, is more effective than clomiphene alone or metformin alone improves fertility outcomes in women with PCOS of reasonably healthy body weight (BMI </= 32).
- Metformin improves fertility outcomes in women with BMI > 32 with PCOS.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Metformin, Placebo, Metformin + Clomiphene, Clomiphene
- Keywords
- Polycystic ovary syndrome, PCOS, Anovulation, Infertility, Anovulatory polycystic ovary syndrome (PCOS)
- Medical subject headings
- Polycystic Ovary Syndrome, Anovulation, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
500mg tds for 6 months
PlaceboDrug
One tablet tds for 6 months
Metformin + ClomipheneDrug
500mg tds + Ovulatory dose for 6 months
MetforminDrug
500mg tds for 6 months
ClomipheneDrug
Ovulatory dose for 6 months
| Study group | Role | What they receive |
|---|---|---|
| BMI > 32 | Experimental | Women with BMI > 32 Receives: Drug: Metformin; Drug: Placebo |
| BMI </= 32 | Experimental | Women with BMI </= 32 Receives: Drug: Metformin + Clomiphene; Drug: Metformin; Drug: Clomiphene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy
Measured: within 6 calendar months of randomisation
Secondary outcomes (2)
Live birth
Adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2008 (estimated)
- Study startAug 2003
- Primary completionOct 2008
- Study completionOct 2008
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 Polycystic Ovary SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Auckland, New Zealand
- Sponsor type
- University, hospital or other
- Collaborators
- Auckland Medical Research Foundation, Mercia Barnes Trust of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists
- Investigators
- Neil P Johnson, FRANZCOG, Principal investigator, University of Auckland, fertility Plus & Repromed Auckland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00795808
- Sponsor's protocol ID
- UAuckland
- Acronym
- PCOSMIC
- Status last verified
- Nov 2008
- First submitted
- 20 Nov 2008
- Last updated
- 21 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Johnson NP, Stewart AW, Falkiner J, Farquhar CM, Milsom S, Singh VP, Okonkwo QL, Buckingham KL; REACT-NZ (REproduction And Collaborative Trials in New Zealand), a multi-centre fertility trials group. PCOSMIC: a multi-centre randomized trial in women with PolyCystic Ovary Syndrome evaluating Metformin for Infertility with Clomiphene. Hum Reprod. 2010 Jul;25(7):1675-83. doi: 10.1093/humrep/deq100. Epub 2010 Apr 30.
PubMed 20435692
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Centre Randomised Controlled Trial of the Effectiveness of Metformin and Clomiphene Citrate for Treating Anovulatory Infertility in Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT00795808
- Acronym / sponsor ID
- PCOSMIC / UAuckland
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Polycystic ovary syndrome, PCOS, Anovulation, Infertility, Anovulatory polycystic ovary syndrome (PCOS)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- University of Auckland, New ZealandUniversity, hospital or other
- Collaborators
- Auckland Medical Research Foundation, Mercia Barnes Trust of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists
- Study start
- Aug 2003
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 21 Nov 2008 (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.
- Metformin increases the pregnancy rate when added to the standard treatment of anovulatory polycystic ovary syndrome (PCOS).
- Metformin in combination with clomiphene, is more effective than clomiphene alone or metformin alone improves fertility outcomes in women with PCOS of reasonably healthy body weight (BMI </= 32).
- Metformin improves fertility outcomes in women with BMI > 32 with PCOS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMI > 32 | Experimental | Drug: Metformin, Drug: PlaceboWomen with BMI > 32 |
| BMI </= 32 | Experimental | Drug: Metformin + Clomiphene, Drug: Metformin, Drug: ClomipheneWomen with BMI </= 32 |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women between the age of 18 and 39 years inclusive.
- Anovulatory infertility of duration at least 12 months.
- Polycystic ovary syndrome, based on Rotterdam consensus criteria.
- Normal serum prolactin, thyroid function and 17-hydroxyprogesterone.
- Normal serum prolactin, thyroid function and 17-hydroxyprogesterone;
Key exclusion criteria (13 listed)
- Presence of any other significant infertility factor including male factor, known tubal disease or history of an ectopic pregnancy, known endometriosis affecting the fallopian tubes or ovaries.
- Already taking oral hypoglycaemics.
- Diabetics receiving treatment.
- Renal impairment
- Chronic hepatic disease
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 |
|---|---|---|
| Metformin500mg tds for 6 months | Drug | BMI > 32 |
| PlaceboOne tablet tds for 6 months | Drug | BMI > 32 |
| Metformin + Clomiphene500mg tds + Ovulatory dose for 6 months | Drug | BMI </= 32 |
| Metformin500mg tds for 6 months | Drug | BMI </= 32 |
| ClomipheneOvulatory dose for 6 months | Drug | BMI </= 32 |
Primary outcome
Clinical pregnancy
Time frame: within 6 calendar months of randomisation
2 secondary outcomes
Live birth
Adverse events
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 21 Nov 2008.
- Derived from this study: PubMed 20435692Johnson NP, Stewart AW, Falkiner J, Farquhar CM, Milsom S, Singh VP, Okonkwo QL, Buckingham KL; REACT-NZ (REproduction And Collaborative Trials in New Zealand), a multi-centre fertility trials group. PCOSMIC: a multi-centre randomized trial in women with PolyCystic Ovary Syndrome evaluating Metformin for Infertility with Clomiphene. Hum Reprod. 2010 Jul;25(7):1675-83. doi: 10.1093/humrep/deq100. Epub 2010 Apr 30.
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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.
Neil P Johnson, FRANZCOG principal investigator
University of Auckland, fertility Plus & Repromed Auckland
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, Metformin + Clomiphene and Clomiphene in people with Polycystic Ovary Syndrome, run by University of Auckland, New Zealand at 1 site in New Zealand.
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 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: finished, as of the sponsor's last update on 21 Nov 2008. 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 New Zealand. 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.
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?
Clinical pregnancy (time frame: within 6 calendar months of randomisation). 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 NCT00795808, 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 21 Nov 2008.