InfertilityPhase 4NCT01208740
Metformin in Patients With PCOS and Predictors of Poor Ovarian Response Ongoing In-vitro Fertilization
A Phase 4 study testing Metformin in people with Infertility and PCOS, run by University Magna Graecia at 1 site in Italy.
Trial summary
Metformin should be administered with caution and could be potentially dangerous in infertile patients with PCOS who show a poor ovarian response and are undergoing gonadotropin-based ovarian stimulation. However, data that address this point are totally lacking. Read more about this study
- Who is it for?
- Ages 35 to 45 years, women only
- Conditions the study is for
- Infertility, PCOS, Prognosis for Poor Response
- What is being tested?
- Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2009to Mar 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 35 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- PCOS
- Prognosis for poor response
- Infertility
Who cannot join
- Male factor infertility
- Tubal infertility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Metformin on the Ovarian Response to Gonadotropins for in Vitro Fertilization Treatment in Patients With Polycystic Ovary Syndrome and Predictors of Poor Ovarian Response
Metformin should be administered with caution and could be potentially dangerous in infertile patients with PCOS who show a poor ovarian response and are undergoing gonadotropin-based ovarian stimulation. However, data that address this point are totally lacking.
On the basis of these considerations, the aim of the current clinical trial was to test the hypothesis that metformin reduces the ovarian response in infertile patients with PCOS who have a potentially poor ovarian response and who undergo gonadotropin stimulation for IVF cycles.
Read the detailed description
Primary infertile patients with PCOS older than 35 years and/or with a basal follicle-stimulating hormone (FSH) level higher than 10 IU/L who were scheduled for IVF cycles were enrolled in the study protocol.
- Conditions
- Infertility, PCOS, Prognosis for Poor Response
- Being tested
- Metformin, Placebo
- Keywords
- Gonadotropins, infertility, IVF, metformin, PCOS, poor prognosis, poor responder
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
500 mg three times daily
PlaceboDrug
1 pill three times daily
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Experimental | Metformin pre-treatment and co-administration Receives: Drug: Metformin |
| Placebo | Placebo comparator | Placebo pre-treatment and co-administration Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of cancellation due to low ovarian response
Number of cancelled cycles/total cycles
Measured: one month
Secondary outcomes (6)
Stimulation length
Measured: one month
Gonadotropins dose
Measured: one month
Ovulation rate
Measured: one month
pregnancy rate
Measured: one month
Live-birth rate
Measured: nine months
Adverse effects
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2010 (estimated)
- Study startJan 2009
- Primary completionOct 2010
- Study completionMar 2011
Why it stopped: Concerns about safety at the first interim analysis
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 InfertilityStudies 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
- 88 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
- NCT01208740
- Sponsor's protocol ID
- 02/2010
- Status last verified
- May 2011
- First submitted
- 24 May 2010
- Last updated
- 24 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Palomba S, Falbo A, Di Cello A, Cappiello F, Tolino A, Zullo F. Does metformin affect the ovarian response to gonadotropins for in vitro fertilization treatment in patients with polycystic ovary syndrome and reduced ovarian reserve? A randomized controlled trial. Fertil Steril. 2011 Nov;96(5):1128-33. doi: 10.1016/j.fertnstert.2011.08.020. Epub 2011 Sep 13.
PubMed 21917254
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
- Effects of Metformin on the Ovarian Response to Gonadotropins for in Vitro Fertilization Treatment in Patients With Polycystic Ovary Syndrome and Predictors of Poor Ovarian Response
- ClinicalTrials.gov ID
- NCT01208740
- Acronym / sponsor ID
- 02/2010
- Conditions
- Infertility, PCOS, Prognosis for Poor Response
- Keywords
- Gonadotropins, infertility, IVF, metformin, PCOS, poor prognosis, poor responder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Concerns about safety at the first interim analysis
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University Magna GraeciaUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 24 Sep 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.
Metformin should be administered with caution and could be potentially dangerous in infertile patients with PCOS who show a poor ovarian response and are undergoing gonadotropin-based ovarian stimulation. However, data that address this point are totally lacking.
On the basis of these considerations, the aim of the current clinical trial was to test the hypothesis that metformin reduces the ovarian response in infertile patients with PCOS who have a potentially poor ovarian response and who undergo gonadotropin stimulation for IVF cycles.
Detailed description
Primary infertile patients with PCOS older than 35 years and/or with a basal follicle-stimulating hormone (FSH) level higher than 10 IU/L who were scheduled for IVF cycles were enrolled in the study protocol.
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 |
|---|---|---|
| Metformin | Experimental | Drug: MetforminMetformin pre-treatment and co-administration |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo pre-treatment and co-administration |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- PCOS
- Prognosis for poor response
- Infertility
Key exclusion criteria (2 listed)
- Male factor infertility
- Tubal infertility
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 |
|---|---|---|
| Metformin500 mg three times daily | Drug | Metformin |
| Placebo1 pill three times daily | Drug | Placebo |
Primary outcome
Rate of cancellation due to low ovarian response
Time frame: one month
Number of cancelled cycles/total cycles
6 secondary outcomes
Stimulation length
Time frame: one month
Gonadotropins dose
Time frame: one month
Ovulation rate
Time frame: one month
pregnancy rate
Time frame: one month
Live-birth rate
Time frame: nine months
Adverse effects
Time frame: one month
Results and safety
The study was stopped early (reason given: Concerns about safety at the first interim analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2011.
- Derived from this study: PubMed 21917254Palomba S, Falbo A, Di Cello A, Cappiello F, Tolino A, Zullo F. Does metformin affect the ovarian response to gonadotropins for in vitro fertilization treatment in patients with polycystic ovary syndrome and reduced ovarian reserve? A randomized controlled trial. Fertil Steril. 2011 Nov;96(5):1128-33. doi: 10.1016/j.fertnstert.2011.08.020. Epub 2011 Sep 13.
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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.
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 in people with Infertility and PCOS, 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 3 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: stopped early, 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 was stopped early (reason given: Concerns about safety at the first interim analysis). Results are not available in the source record.
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?
Rate of cancellation due to low ovarian response (time frame: one month). 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 NCT01208740, 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 24 May 2011.