InfertilityPhase 4NCT00471523
Treatment of Anovulatory Infertility in PCOS Patients
A Phase 4 study testing Clomiphene citrate and Metformin in people with Infertility and Polycystic Ovary Syndrome, run by University Magna Graecia at 1 site in Italy.
Trial summary
Clomiphene citrate (CC) and metformin are two effective drugs used to induce ovulation in patients with polycystic ovary syndrome (PCOS), even if it is still unclear which compound between them should be initially administered. Read more about this study
- Who is it for?
- Ages 18 to 41 years, women only
- Conditions the study is for
- Infertility, Polycystic Ovary Syndrome, Anovulation
- What is being tested?
- Clomiphene citrate and Metformin
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- May 2006to Mar 2007
- 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 41 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Anovulatory infertility related to polycystic ovary syndrome
Who cannot join
- Neoplastic, metabolic, hepatic, and cardiovascular disorders or other concurrent medical illnesses
- Hypothyroidism, hyperprolactinemia, Cushing's syndrome, and non-classical congenital adrenal hyperplasia
- Current or previous (within the last six months) use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other hormonal drugs.
- Organic pelvic diseases
- Previous pelvic surgery
- Suspected peritoneal factor infertility
- Tubal or male factor infertility or sub-fertility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clomiphene Citrate Versus Metformin as First-Line Approach for the Treatment of Anovulation in Infertile Patients With Polycystic Ovary Syndrome
Clomiphene citrate (CC) and metformin are two effective drugs used to induce ovulation in patients with polycystic ovary syndrome (PCOS), even if it is still unclear which compound between them should be initially administered. The aim of the study will be to compare in a clinical setting the efficacy of CC and metformin as first-line approaches for treating anovulation in infertile PCOS patients.
Read the detailed description
Eighty infertile anovulatory patients with PCOS will be allocated in two body mass index (BMI)- and age-matched groups (experimental and control groups).
Forty patients will receive the experimental treatment consisting of six months of 1700 mg/day metformin administration (experimental group), whereas other forty patients will receive CC administered using a traditional incremental-doses protocol (control group). In both groups, patients who will ovulate under treatment will continue the therapy for a total of six months.
During the study, the clinical and reproductive outcomes, and the adverse experience will be evaluated in each patient.
- Conditions
- Infertility, Polycystic Ovary Syndrome, Anovulation
- Being tested
- Clomiphene citrate, Metformin
- Keywords
- Anovulation, Clomiphene citrate, Infertility, Metformin, PCOS, Treatment
- Medical subject headings
- Infertility, Polycystic Ovary Syndrome, Anovulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clomiphene citrateDrug
MetforminDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate
Measured: 10 months
Secondary outcomes (5)
Ovulation rate
Measured: 6 months
Abortion rate
Measured: 10 months
Time to first pregnancy
Measured: 10 months
Adverse events
Measured: 10 months
N. pregnancies/n. ovulatory cycles
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2007 (estimated)
- Study startMay 2006
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Magna Graecia
- Sponsor type
- University, hospital or other
- Investigators
- Stefano Palomba, MD, Principal investigator, Department of Obstetrics & Gynecology, University "Magna Graecia" of CatanzaroAchille Tolino, MD, Principal investigator, Department of Obstetrics & Gynecology, University "Federico II" of NaplesFrancesco Orio, MD, Principal investigator, Department of Endocrinology, University "Federico II" of Naples
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00471523
- Sponsor's protocol ID
- 02-2006
- Status last verified
- May 2007
- First submitted
- 8 May 2007
- Last updated
- 10 May 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Palomba S, Orio F Jr, Falbo A, Manguso F, Russo T, Cascella T, Tolino A, Carmina E, Colao A, Zullo F. Prospective parallel randomized, double-blind, double-dummy controlled clinical trial comparing clomiphene citrate and metformin as the first-line treatment for ovulation induction in nonobese anovulatory women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2005 Jul;90(7):4068-74. doi: 10.1210/jc.2005-0110. Epub 2005 Apr 19.
PubMed 15840746Palomba S, Orio F Jr, Falbo A, Russo T, Tolino A, Zullo F. Effects of metformin and clomiphene citrate on ovarian vascularity in patients with polycystic ovary syndrome. Fertil Steril. 2006 Dec;86(6):1694-701. doi: 10.1016/j.fertnstert.2006.05.035. Epub 2006 Oct 30.
PubMed 17074337Palomba S, Orio F, Zullo F. Ovulation induction in women with polycystic ovary syndrome. Fertil Steril. 2006 Jul;86 Suppl 1:S26-7. doi: 10.1016/j.fertnstert.2006.03.018.
PubMed 16798282Palomba S, Russo T, Orio F Jr, Falbo A, Manguso F, Sammartino A, Tolino A, Colao A, Carmina E, Zullo F. Uterine effects of clomiphene citrate in women with polycystic ovary syndrome: a prospective controlled study. Hum Reprod. 2006 Nov;21(11):2823-9. doi: 10.1093/humrep/del267. Epub 2006 Jul 10.
PubMed 16835214Palomba S, Falbo A, Orio F Jr, Tolino A, Zullo F. Efficacy predictors for metformin and clomiphene citrate treatment in anovulatory infertile patients with polycystic ovary syndrome. Fertil Steril. 2009 Jun;91(6):2557-67. doi: 10.1016/j.fertnstert.2008.03.011. Epub 2008 Apr 28.
PubMed 18440534
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clomiphene Citrate Versus Metformin as First-Line Approach for the Treatment of Anovulation in Infertile Patients With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT00471523
- Acronym / sponsor ID
- 02-2006
- Conditions
- Infertility, Polycystic Ovary Syndrome, Anovulation
- Keywords
- Anovulation, Clomiphene citrate, Infertility, Metformin, PCOS, Treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Magna GraeciaUniversity, hospital or other
- Study start
- May 2006
- Study completion
- Mar 2007 (actual)
- First posted
- 10 May 2007 (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.
Clomiphene citrate (CC) and metformin are two effective drugs used to induce ovulation in patients with polycystic ovary syndrome (PCOS), even if it is still unclear which compound between them should be initially administered. The aim of the study will be to compare in a clinical setting the efficacy of CC and metformin as first-line approaches for treating anovulation in infertile PCOS patients.
Detailed description
Eighty infertile anovulatory patients with PCOS will be allocated in two body mass index (BMI)- and age-matched groups (experimental and control groups).
Forty patients will receive the experimental treatment consisting of six months of 1700 mg/day metformin administration (experimental group), whereas other forty patients will receive CC administered using a traditional incremental-doses protocol (control group). In both groups, patients who will ovulate under treatment will continue the therapy for a total of six months.
During the study, the clinical and reproductive outcomes, and the adverse experience will be evaluated in each patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 41 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Anovulatory infertility related to polycystic ovary syndrome
Key exclusion criteria (7 listed)
- Neoplastic, metabolic, hepatic, and cardiovascular disorders or other concurrent medical illnesses
- Hypothyroidism, hyperprolactinemia, Cushing's syndrome, and non-classical congenital adrenal hyperplasia
- Current or previous (within the last six months) use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other hormonal drugs.
- Organic pelvic diseases
- Previous pelvic surgery
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 |
|---|---|---|
| Clomiphene citrate | Drug | – |
| Metformin | Drug | – |
Primary outcome
Pregnancy rate
Time frame: 10 months
5 secondary outcomes
Ovulation rate
Time frame: 6 months
Abortion rate
Time frame: 10 months
Time to first pregnancy
Time frame: 10 months
Adverse events
Time frame: 10 months
N. pregnancies/n. ovulatory cycles
Time frame: 10 months
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 10 May 2007.
- Background: PubMed 15840746Palomba S, Orio F Jr, Falbo A, Manguso F, Russo T, Cascella T, Tolino A, Carmina E, Colao A, Zullo F. Prospective parallel randomized, double-blind, double-dummy controlled clinical trial comparing clomiphene citrate and metformin as the first-line treatment for ovulation induction in nonobese anovulatory women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2005 Jul;90(7):4068-74. doi: 10.1210/jc.2005-0110. Epub 2005 Apr 19.
- Background: PubMed 17074337Palomba S, Orio F Jr, Falbo A, Russo T, Tolino A, Zullo F. Effects of metformin and clomiphene citrate on ovarian vascularity in patients with polycystic ovary syndrome. Fertil Steril. 2006 Dec;86(6):1694-701. doi: 10.1016/j.fertnstert.2006.05.035. Epub 2006 Oct 30.
- Background: PubMed 16798282Palomba S, Orio F, Zullo F. Ovulation induction in women with polycystic ovary syndrome. Fertil Steril. 2006 Jul;86 Suppl 1:S26-7. doi: 10.1016/j.fertnstert.2006.03.018.
- Background: PubMed 16835214Palomba S, Russo T, Orio F Jr, Falbo A, Manguso F, Sammartino A, Tolino A, Colao A, Carmina E, Zullo F. Uterine effects of clomiphene citrate in women with polycystic ovary syndrome: a prospective controlled study. Hum Reprod. 2006 Nov;21(11):2823-9. doi: 10.1093/humrep/del267. Epub 2006 Jul 10.
- Derived from this study: PubMed 18440534Palomba S, Falbo A, Orio F Jr, Tolino A, Zullo F. Efficacy predictors for metformin and clomiphene citrate treatment in anovulatory infertile patients with polycystic ovary syndrome. Fertil Steril. 2009 Jun;91(6):2557-67. doi: 10.1016/j.fertnstert.2008.03.011. Epub 2008 Apr 28.
Related trials for Infertility
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
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.
Stefano Palomba, MD principal investigator
Department of Obstetrics & Gynecology, University "Magna Graecia" of Catanzaro
Achille Tolino, MD principal investigator
Department of Obstetrics & Gynecology, University "Federico II" of Naples
Francesco Orio, MD principal investigator
Department of Endocrinology, University "Federico II" of Naples
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 Clomiphene citrate and Metformin in people with Infertility 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 1 inclusion and 7 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 10 May 2007. 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. 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?
Pregnancy rate (time frame: 10 months). 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 NCT00471523, which also lists 5 linked publications.
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 10 May 2007.