InfertilityNCT01046708
Luteal Support and Intrauterine Insemination (IUI) With Clomiphene Citrate
A study testing micronized progesterone in people with Infertility, run by Universitair Ziekenhuis Brussel.
Trial summary
The purpose of this study is to assess the effect of luteal phase supplement (LPS) on pregnancy rate in IUI cycles stimulated with clomiphene citrate. Read more about this study
- Who is it for?
- Ages 18 to 36 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- micronized progesterone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Jul 2012
- Phase
- Interventional
- 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 36 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age ≤ 36 years
- Body mass index between 18 and 29
- Presence of both ovaries
- Basal levels of estradiol (≤ 80 pg/ml) and progesterone (≤ 1.6ng/ml) on day one of the cycle and a day three FSH level of <12IU/L
- Patients can enter the study only once.
- Only the first IUI attempt will be included ( at the 2nd and 3 rd attempt progesterone could be administrated if it is necessary but these attempts will be excluded from the study)
- Normal HSG (maximum 3 months prior starting the stimulation).
- Donor sperm can be included
Who cannot join
- Polycystic ovarian syndrome (Rotterdam criteria)
- Endometriosis(≥AFS III)
About this study
Official title: Ovulation Induction With Clomiphene Citrate: to Support or Not to Support the Luteal Phase
The purpose of this study is to assess the effect of luteal phase supplement (LPS) on pregnancy rate in IUI cycles stimulated with clomiphene citrate.
- Conditions
- Infertility
- Being tested
- micronized progesterone
- Keywords
- IUI, clomiphene citrate, utrogestan
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
micronized progesteroneDrug
Also called utrogestan
600mg in 3 separate doses per day
| Study group | Role | What they receive |
|---|---|---|
| micronized progesterone | Experimental | Not described Receives: Drug: micronized progesterone |
| no utrogestan | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
ongoing pregnancy rate
Measured: 1 year
Secondary outcomes (1)
implantation rate,clinical pregnancy rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2010 (estimated)
- Study startSep 2008
- Primary completionAug 2009
- Study completionJul 2012
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.
- More trials run by Universitair Ziekenhuis BrusselThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyrou Dimitra, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01046708
- Sponsor's protocol ID
- CFER
- Status last verified
- Jul 2013
- First submitted
- 11 Jan 2010
- Last updated
- 3 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Kyrou D, Fatemi HM, Tournaye H, Devroey P. Luteal phase support in normo-ovulatory women stimulated with clomiphene citrate for intrauterine insemination: need or habit? Hum Reprod. 2010 Oct;25(10):2501-6. doi: 10.1093/humrep/deq223. Epub 2010 Aug 18.
PubMed 20719809
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ovulation Induction With Clomiphene Citrate: to Support or Not to Support the Luteal Phase
- ClinicalTrials.gov ID
- NCT01046708
- Acronym / sponsor ID
- CFER
- Conditions
- Infertility
- Keywords
- IUI, clomiphene citrate, utrogestan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 12 Jan 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.
The purpose of this study is to assess the effect of luteal phase supplement (LPS) on pregnancy rate in IUI cycles stimulated with clomiphene citrate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| micronized progesterone | Experimental | Drug: micronized progesterone |
| no utrogestan | No intervention | – |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age ≤ 36 years
- Body mass index between 18 and 29
- Presence of both ovaries
- Basal levels of estradiol (≤ 80 pg/ml) and progesterone (≤ 1.6ng/ml) on day one of the cycle and a day three FSH level of <12IU/L
- Patients can enter the study only once.
Key exclusion criteria (2 listed)
- Polycystic ovarian syndrome (Rotterdam criteria)
- Endometriosis(≥AFS III)
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 |
|---|---|---|
| micronized progesteroneAlso: utrogestan600mg in 3 separate doses per day | Drug | micronized progesterone |
Primary outcome
ongoing pregnancy rate
Time frame: 1 year
1 secondary outcome
implantation rate,clinical pregnancy rate
Time frame: 1 year
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 3 Jul 2013.
- Derived from this study: PubMed 20719809Kyrou D, Fatemi HM, Tournaye H, Devroey P. Luteal phase support in normo-ovulatory women stimulated with clomiphene citrate for intrauterine insemination: need or habit? Hum Reprod. 2010 Oct;25(10):2501-6. doi: 10.1093/humrep/deq223. Epub 2010 Aug 18.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing micronized progesterone in people with Infertility, run by Universitair Ziekenhuis Brussel.
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 8 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: finished, as of the sponsor's last update on 3 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
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.
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 rate (time frame: 1 year). 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 NCT01046708, 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 3 Jul 2013.