InfertilityPhase 4NCT00993902
Double and Single Intrauterine Insemination In Controlled Ovarian Stimulation (COH) Cycles With Multifollicular Development
A Phase 4 study testing Intrauterine insemination (single) and Double intrauterine insemination in people with Infertility, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
Our hypothesis is double insemination will improve pregnancy rates in coh cycles with more than one dominant follicles (>16mm). Read more about this study
- Who is it for?
- Ages 20 to 37 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Intrauterine insemination (single) and Double intrauterine insemination
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 228 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2008to Jul 2009
- 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 20 to 37 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Unexplained and mild male factor infertile patients
- Minimum 2 follicles >16 mm at the day of HCG
- First 3 cycles
Who cannot join
- Basal FSH >12 mIU/L
- Total antral follicle count<6
- Severe male factor infertility
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Baskent University Medical Faculty Obstetric and Gynecelogy Department, Infertility and IVF unit
Adana, 01120
About this study
Our hypothesis is double insemination will improve pregnancy rates in coh cycles with more than one dominant follicles (>16mm).
Read the detailed description
Metaanalysis for the effects of double IUI demonstrates that effects of this procedure is not different from single IUI. It is known that nearly 25% of coh cycles is evident by monofollicular development.For this reason it is possible that this monofollicular cycles in the studies could decrease the effects of double IUI.
Inclusion criteria:
- Patients with unexplained infertility or mild male factor infertility whom admitted to the COH+IUI programme in our infertility unit.
- Female age <37 years old.
- Baseline FSH <12 mIU/L
- Total antral follicle count>6
- During the first three cycles of COH+IUI
- Minimum 2 follicles >16 mm at the day of HCG.
Primary outcome:
Ongoing pregnancy rates
Secondary outcomes:
The effects of different coh regimens (CC,FSH,CC+FSH)on the outcomes.
- Conditions
- Infertility
- Being tested
- Intrauterine insemination (single), Double intrauterine insemination
- Keywords
- Double IUI, Intrauterine insemination, Unexplained infertility
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrauterine insemination (single)Procedure or surgery
Also called Group I
Single IUI after 36-38 hours of HCG
Double intrauterine inseminationProcedure or surgery
Also called Grup II
Double insemination after 18 and 40 hours of HCG administration.
| Study group | Role | What they receive |
|---|---|---|
| Single IUI | Sham comparator | Single IUI will be carried on after 36-38 hours of HCG administration Receives: Procedure: Intrauterine insemination (single) |
| Double IUI | Active comparator | Not described Receives: Procedure: Double intrauterine insemination |
What is being measured
The primary outcome is the main question the study is designed to answer.
ongoing pregnancy rates
Measured: pregnancy >12 weeks of gestation
Secondary outcomes (1)
The effects of different coh regimens on outcomes
Measured: 14 days after IUI procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startMay 2008
- Primary completionMay 2009
- Study completionJul 2009
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
- None (open label)
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00993902
- Sponsor's protocol ID
- BU1
- Status last verified
- Oct 2009
- First submitted
- 22 Jul 2009
- Last updated
- 14 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Bagis T, Haydardedeoglu B, Kilicdag EB, Cok T, Simsek E, Parlakgumus AH. Single versus double intrauterine insemination in multi-follicular ovarian hyperstimulation cycles: a randomized trial. Hum Reprod. 2010 Jul;25(7):1684-90. doi: 10.1093/humrep/deq112. Epub 2010 May 10.
PubMed 20457669
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double and Single Intrauterine Insemination In Controlled Ovarian Stimulation (COH) Cycles With Multifollicular Development
- ClinicalTrials.gov ID
- NCT00993902
- Acronym / sponsor ID
- BU1
- Conditions
- Infertility
- Keywords
- Double IUI, Intrauterine insemination, Unexplained infertility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 14 Oct 2009 (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.
Our hypothesis is double insemination will improve pregnancy rates in coh cycles with more than one dominant follicles (>16mm).
Detailed description
Metaanalysis for the effects of double IUI demonstrates that effects of this procedure is not different from single IUI. It is known that nearly 25% of coh cycles is evident by monofollicular development.For this reason it is possible that this monofollicular cycles in the studies could decrease the effects of double IUI.
Inclusion criteria:
- Patients with unexplained infertility or mild male factor infertility whom admitted to the COH+IUI programme in our infertility unit.
- Female age <37 years old.
- Baseline FSH <12 mIU/L
- Total antral follicle count>6
- During the first three cycles of COH+IUI
- Minimum 2 follicles >16 mm at the day of HCG.
Primary outcome:
Ongoing pregnancy rates
Secondary outcomes:
The effects of different coh regimens (CC,FSH,CC+FSH)on the outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single IUI | Sham comparator | Procedure: Intrauterine insemination (single)Single IUI will be carried on after 36-38 hours of HCG administration |
| Double IUI | Active comparator | Procedure: Double intrauterine insemination |
Who may qualify
- Ages
- 20 to 37 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Unexplained and mild male factor infertile patients
- Minimum 2 follicles >16 mm at the day of HCG
- First 3 cycles
Key exclusion criteria (3 listed)
- Basal FSH >12 mIU/L
- Total antral follicle count<6
- Severe 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 (single)Also: Group ISingle IUI after 36-38 hours of HCG | Procedure or surgery | Single IUI |
| Double intrauterine inseminationAlso: Grup IIDouble insemination after 18 and 40 hours of HCG administration. | Procedure or surgery | Double IUI |
Primary outcome
ongoing pregnancy rates
Time frame: pregnancy >12 weeks of gestation
1 secondary outcome
The effects of different coh regimens on outcomes
Time frame: 14 days after IUI procedure
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 14 Oct 2009.
- Derived from this study: PubMed 20457669Bagis T, Haydardedeoglu B, Kilicdag EB, Cok T, Simsek E, Parlakgumus AH. Single versus double intrauterine insemination in multi-follicular ovarian hyperstimulation cycles: a randomized trial. Hum Reprod. 2010 Jul;25(7):1684-90. doi: 10.1093/humrep/deq112. Epub 2010 May 10.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 (single) and Double intrauterine insemination in people with Infertility, run by Baskent University at 1 site in Turkey (Türkiye).
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 3 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 14 Oct 2009. 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 Turkey (Türkiye). 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 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?
ongoing pregnancy rates (time frame: pregnancy >12 weeks of gestation). 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 NCT00993902, 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 14 Oct 2009.