Polycystic Ovary SyndromePhase 4NCT00502281
Controlled Ovarian Stimulation Followed by Timed Intercourse or Intrauterine Insemination in Infertile PCOS Patients
A Phase 4 study testing highly purified urinary FSH and timed intercourses, intrauterine insemination in people with Polycystic Ovary Syndrome, run by University Magna Graecia at 1 site in Italy.
Trial summary
At the present the first options to induce ovulation in polycystic ovary syndrome with anovulatory infertility are clomiphene citrate (CC) and metformin. Notwithstanding the effectiveness of CC and metformin alone or in a sequential or combined regimen, a percentage of patients ranging from 5% to 30% remain… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- highly purified urinary FSH and timed intercourses, intrauterine insemination
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2007to Mar 2013
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Polycystic ovary syndrome (using NIH criteria)
- Anovulatory infertility (using WHO criteria)
Who cannot join
- Age <18 or >35 years
- Severe obesity (BMI >35)
- 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, anti-obesity drugs, hormonal drugs
- Intention to start a diet or a specific program of physical activity
Show all 10Show fewer
- 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: Timed Intercourse Versus Intrauterine Insemination in Infertile Patients Undergoing Gonadotropin Ovarian Stimulation
At the present the first options to induce ovulation in polycystic ovary syndrome with anovulatory infertility are clomiphene citrate (CC) and metformin. Notwithstanding the effectiveness of CC and metformin alone or in a sequential or combined regimen, a percentage of patients ranging from 5% to 30% remain anovulatory. For these patients, the use of gonadotropins for controlled ovarian stimulation (COS) is indicated.
Moreover, to date it isn't clear if COS should be followed by timed intercourse (TI) or intrauterine insemination (IUI).
The aim of the present study will be to compare TI and IUI in infertile PCOS patients undergoing COS in terms of cost-benefit.
Read the detailed description
Infertile PCOS patients who remain anovulatory after CC or metformin treatment will be enrolled. All patients will receive gonadotropins in low-dose step-up protocol for COS, and randomized to receive three trials of TI (group A) or IUI (group B).
All patients eligible will undergo baseline assessment consisting of anthropometric, hormonal, and ultrasonographic evaluations.
In all patients the COS will be obtained using highly purified urinary FSH in a low-dose step-up protocol, and both TI and IUI will be performed after 35 hours from ovulation induction with human chorionic gonadotropin.
During the study, the clinical and reproductive outcomes, the adverse experience will be evaluated in each patient.
Data will be analyzed using the intention-to-treat principle and a P value of 0.05 or less will be considered significant. Continuous variables will be analyzed with the unpaired t test and general linear model for repeated measures analysis with Bonferroni test for the post-hoc analysis as required. For categorical variables, the Pearson chi-square and Fisher's exact tests will be used. Cumulative pregnancy rate, our primary end-point, will be calculated by the Kaplan-Maier method, and the differences between the two groups will be assessed with the log-rank test. Cox proportional-hazards model will be used to calculate the hazard ratio for new pregnancy in both groups.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- highly purified urinary FSH, timed intercourses, intrauterine insemination
- Keywords
- Gonadotropins, Infertility, Intrauterine insemination, PCOS, Timed intercourse, Treatment
- Medical subject headings
- Polycystic Ovary Syndrome, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
highly purified urinary FSHDrug
timed intercourses, intrauterine inseminationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | COS followed by TI Receives: Drug: highly purified urinary FSH; Behavioral: timed intercourses, intrauterine insemination |
| Group B | Active comparator | COS followed by IUI Receives: Drug: highly purified urinary FSH; Behavioral: timed intercourses, intrauterine insemination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate
Measured: 3 months
Secondary outcomes (5)
Abortion rate
Measured: 3 months
Adverse events
Measured: 3 months
OHSS
Measured: 3 months
Multiple pregnancy rate
Measured: 3 months
Costs
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2007 (estimated)
- Study startJan 2007
- Primary completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Magna Graecia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Palomba, University Magna Graecia
- Investigators
- Stefano Palomba, MD, Principal investigator, Department of Obstetrics & Gynecology, University "Magna Graecia" of CatanzaroFrancesco Orio, MD, Principal investigator, Department of Endocrinology, University "Federico II" of NaplesAchille Tolino, MD, Principal investigator, Department of Obstetrics & Gynecology, University "Federico II" of Naples
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00502281
- Sponsor's protocol ID
- 05/2006e
- Status last verified
- Apr 2013
- First submitted
- 12 Jul 2007
- Last updated
- 9 Apr 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timed Intercourse Versus Intrauterine Insemination in Infertile Patients Undergoing Gonadotropin Ovarian Stimulation
- ClinicalTrials.gov ID
- NCT00502281
- Acronym / sponsor ID
- 05/2006e
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Gonadotropins, Infertility, Intrauterine insemination, PCOS, Timed intercourse, Treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Magna GraeciaUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Mar 2013 (actual)
- First posted
- 17 Jul 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.
At the present the first options to induce ovulation in polycystic ovary syndrome with anovulatory infertility are clomiphene citrate (CC) and metformin. Notwithstanding the effectiveness of CC and metformin alone or in a sequential or combined regimen, a percentage of patients ranging from 5% to 30% remain anovulatory. For these patients, the use of gonadotropins for controlled ovarian stimulation (COS) is indicated.
Moreover, to date it isn't clear if COS should be followed by timed intercourse (TI) or intrauterine insemination (IUI).
The aim of the present study will be to compare TI and IUI in infertile PCOS patients undergoing COS in terms of cost-benefit.
Detailed description
Infertile PCOS patients who remain anovulatory after CC or metformin treatment will be enrolled. All patients will receive gonadotropins in low-dose step-up protocol for COS, and randomized to receive three trials of TI (group A) or IUI (group B).
All patients eligible will undergo baseline assessment consisting of anthropometric, hormonal, and ultrasonographic evaluations.
In all patients the COS will be obtained using highly purified urinary FSH in a low-dose step-up protocol, and both TI and IUI will be performed after 35 hours from ovulation induction with human chorionic gonadotropin.
During the study, the clinical and reproductive outcomes, the adverse experience will be evaluated in each patient.
Data will be analyzed using the intention-to-treat principle and a P value of 0.05 or less will be considered significant. Continuous variables will be analyzed with the unpaired t test and general linear model for repeated measures analysis with Bonferroni test for the post-hoc analysis as required. For categorical variables, the Pearson chi-square and Fisher's exact tests will be used. Cumulative pregnancy rate, our primary end-point, will be calculated by the Kaplan-Maier method, and the differences between the two groups will be assessed with the log-rank test. Cox proportional-hazards model will be used to calculate the hazard ratio for new pregnancy in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: highly purified urinary FSH, Behavioral: timed intercourses, intrauterine inseminationCOS followed by TI |
| Group B | Active comparator | Drug: highly purified urinary FSH, Behavioral: timed intercourses, intrauterine inseminationCOS followed by IUI |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Polycystic ovary syndrome (using NIH criteria)
- Anovulatory infertility (using WHO criteria)
Key exclusion criteria (10 listed)
- Age <18 or >35 years
- Severe obesity (BMI >35)
- 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, anti-obesity drugs, hormonal drugs
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 |
|---|---|---|
| highly purified urinary FSH | Drug | Group A, Group B |
| timed intercourses, intrauterine insemination | Behavioural | Group A, Group B |
Primary outcome
Pregnancy rate
Time frame: 3 months
5 secondary outcomes
Abortion rate
Time frame: 3 months
Adverse events
Time frame: 3 months
OHSS
Time frame: 3 months
Multiple pregnancy rate
Time frame: 3 months
Costs
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2013.
Related trials for Polycystic Ovary Syndrome
Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
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
Francesco Orio, MD principal investigator
Department of Endocrinology, University "Federico II" of Naples
Achille Tolino, MD principal investigator
Department of Obstetrics & Gynecology, 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 highly purified urinary FSH and timed intercourses, intrauterine insemination in people with 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 10 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: paused, as of the sponsor's last update on 9 Apr 2013. 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?
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?
Pregnancy rate (time frame: 3 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 9 Apr 2013.