InfertilityPhase 4OSIPSNCT01675843
Ovarian Stimulation and Intrauterine Insemination in Women With Polycystic Ovarian Syndrome
A Phase 4 study testing Intrauterine insemination (IUI) in people with Infertility and Polycystic Ovarian Syndrome, run by Mansoura University at 1 site in Egypt.
Trial summary
The study null hypothethesis is: intrauterine insemination (IUI) does not improve pregnancy rates in women with polycystic ovary syndrome. Infertile women with pcos will receive gonadotropins for ovarian stimulation and then randomize to either IUI or timed intercourse (TI) Read more about this study
- Who is it for?
- Ages 21 to 38 years, women only
- Conditions the study is for
- Infertility, Polycystic Ovarian Syndrome, Intrauterine Insemination
- What is being tested?
- Intrauterine insemination (IUI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- May 2010to Mar 2012
- 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 21 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women who failed to get pregnant after 6 ovulation induction cycles with clomiphene citrate (cc) alone, despite of being ovulating with cc, having patent Fallopian tubes as confirmed by hysterosalpingography and their partners had fertile semen parameters according to criteria of World Health Organization (WHO 2010)
Who cannot join
- male factor infertility
Trial locations and contacts
1 site in 1 country.
About this study
The study null hypothethesis is: intrauterine insemination (IUI) does not improve pregnancy rates in women with polycystic ovary syndrome. Infertile women with pcos will receive gonadotropins for ovarian stimulation and then randomize to either IUI or timed intercourse (TI)
- Being tested
- Intrauterine insemination (IUI)
- Keywords
- Infertility, PCOS, IUI
- Medical subject headings
- Infertility, Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrauterine insemination (IUI)Procedure or surgery
Also called IUI
The male semen is obtained then processed by swim up technique and then introduced into the uterus by special catheter.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | controlled ovarian hyperstimulation (COH) and intrauterine insemination (IUI) Receives: Procedure: Intrauterine insemination (IUI) |
| Group B | No intervention | Controlled ovarian hyperstimulation (COH)+ Timed Intercourse (TI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live Birth Rate
Measured: 20 months
Secondary outcomes (1)
Clinical pregnancy rate
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2012 (estimated)
- Study startMay 2010
- Primary completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Gibreel, Mansoura University
- Investigators
- Ahmed Gibreel, MD, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01675843
- Sponsor's protocol ID
- AG/4/2010
- Acronym
- OSIPS
- Status last verified
- Aug 2012
- First submitted
- 28 Aug 2012
- Last updated
- 30 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ovarian Stimulation and Intrauterine Insemination in Women With Polycystic Ovarian Syndrome
- ClinicalTrials.gov ID
- NCT01675843
- Acronym / sponsor ID
- OSIPS / AG/4/2010
- Keywords
- Infertility, PCOS, IUI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Mar 2012 (actual)
- First posted
- 30 Aug 2012 (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.
The study null hypothethesis is: intrauterine insemination (IUI) does not improve pregnancy rates in women with polycystic ovary syndrome. Infertile women with pcos will receive gonadotropins for ovarian stimulation and then randomize to either IUI or timed intercourse (TI)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Intrauterine insemination (IUI)controlled ovarian hyperstimulation (COH) and intrauterine insemination (IUI) |
| Group B | No intervention | –Controlled ovarian hyperstimulation (COH)+ Timed Intercourse (TI) |
Who may qualify
- Ages
- 21 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women who failed to get pregnant after 6 ovulation induction cycles with clomiphene citrate (cc) alone, despite of being ovulating with cc, having patent Fallopian tubes as confirmed by hysterosalpingography and their partners had fertile semen parameters according to criteria of World Health Organization (WHO 2010)
Key exclusion criteria (1 listed)
- male factor 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 |
|---|---|---|
| Intrauterine insemination (IUI)Also: IUIThe male semen is obtained then processed by swim up technique and then introduced into the uterus by special catheter. | Procedure or surgery | Group A |
Primary outcome
Live Birth Rate
Time frame: 20 months
1 secondary outcome
Clinical pregnancy rate
Time frame: 16 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 30 Aug 2012.
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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 Gibreel, MD principal investigator
Mansoura University
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 Intrauterine insemination (IUI) in people with Infertility and Polycystic Ovarian Syndrome, run by Mansoura 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 1 inclusion and 1 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 30 Aug 2012. 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. 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?
Live Birth Rate (time frame: 20 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 30 Aug 2012.