InfertilityPhase 4NCT01826747
Intrauterine Insemination and Luteal Fase Support
A Phase 4 study testing crinone (progesterone 8%, vaginal application) in people with Infertility, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The objective is to test the hypothesis that luteal phase support with vaginal progesterone leads to a higher clinical pregnancy rate (primary outcome) and live birth rate (secondary outcome) when compared to no luteal phase support in a program of intrauterine insemination (IUI) after controlled ovarian stimulation… Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- crinone (progesterone 8%, vaginal application)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 393 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2011to Jun 2016
- 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 43 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients with an indication for IUI:
- unexplained infertility
- mild male factor infertility
- minimal-mild endometriosis
- Women:
- first IUI cycle ever
Show all 11Show fewer
- normal ovulatory cycles (26-32d)
- age<43,BMI≤30
- presence of at least one patent tube on hysterosalpingography and/or laparoscopy
- normal uterine cavity (ultrasound, hysterosalpingography, or laparoscopy)
- Men: Total motile count ≥ 5 Million/ml after capacitation
Who cannot join
- Patients with contra-indication for pregnancy , infertility or progesterone use.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Luteal Phase Support With Vaginal Progesterone on the Clinical Pregnancy Rate in Intrauterine Insemination Cycles Stimulated With Gonadotrophins: a Prospective Randomized Multicentre Study.
The objective is to test the hypothesis that luteal phase support with vaginal progesterone leads to a higher clinical pregnancy rate (primary outcome) and live birth rate (secondary outcome) when compared to no luteal phase support in a program of intrauterine insemination (IUI) after controlled ovarian stimulation with gonadotrophins. Additionally, the length of the luteal phase will be recorded (secondary outcome) in order to detect luteal phase defects/insufficiencies in the absence of luteal phase suppletion as well as luteal phase prolongation in case of luteal phase support which may be a burden for the patients waiting for the outcome of the treatment.
- Conditions
- Infertility
- Being tested
- crinone (progesterone 8%, vaginal application)
- Keywords
- intrauterine insemination, luteal phase, gonadotrophins
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
crinone (progesterone 8%, vaginal application)Drug
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | Luteal Phase support Receives: Drug: crinone (progesterone 8%, vaginal application) |
| control | No intervention | No luteal Phase support |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy rate per IUI cycle
Measured: by ultrasound at ± 5 to 6 weeks after IUI
Secondary outcomes (1)
live birth rate per IUI cycle
Measured: 40 weeks after IUI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2013 (estimated)
- Study startApr 2011
- Primary completionJan 2015
- Study completionJun 2016
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 Universitaire Ziekenhuizen KU LeuvenThe 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
- None (open label)
- Enrolment
- 393 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01826747
- Sponsor's protocol ID
- S52775
- Status last verified
- Oct 2018
- First submitted
- 25 Feb 2013
- Last updated
- 19 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Peeraer K, D'Hooghe T, Laurent P, Pelckmans S, Delvigne A, Laenen A, Welkenhuysen M, Wyns C, De Neubourg D. Impact of luteal phase support with vaginal progesterone on the clinical pregnancy rate in intrauterine insemination cycles stimulated with gonadotropins: a randomized multicenter study. Fertil Steril. 2016 Nov;106(6):1490-1495. doi: 10.1016/j.fertnstert.2016.07.1096. Epub 2016 Aug 23.
PubMed 27565253
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Luteal Phase Support With Vaginal Progesterone on the Clinical Pregnancy Rate in Intrauterine Insemination Cycles Stimulated With Gonadotrophins: a Prospective Randomized Multicentre Study.
- ClinicalTrials.gov ID
- NCT01826747
- Acronym / sponsor ID
- S52775
- Conditions
- Infertility
- Keywords
- intrauterine insemination, luteal phase, gonadotrophins
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 393 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Apr 2011 (actual)
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 8 Apr 2013 (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 objective is to test the hypothesis that luteal phase support with vaginal progesterone leads to a higher clinical pregnancy rate (primary outcome) and live birth rate (secondary outcome) when compared to no luteal phase support in a program of intrauterine insemination (IUI) after controlled ovarian stimulation with gonadotrophins. Additionally, the length of the luteal phase will be recorded (secondary outcome) in order to detect luteal phase defects/insufficiencies in the absence of luteal phase suppletion as well as luteal phase prolongation in case of luteal phase support which may be a burden for the patients waiting for the outcome of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Drug: crinone (progesterone 8%, vaginal application)Luteal Phase support |
| control | No intervention | –No luteal Phase support |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- unexplained infertility
- mild male factor infertility
- minimal-mild endometriosis
- first IUI cycle ever
- normal ovulatory cycles (26-32d)
Key exclusion criteria (1 listed)
- Patients with contra-indication for pregnancy , infertility or progesterone use.
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 |
|---|---|---|
| crinone (progesterone 8%, vaginal application) | Drug | experimental |
Primary outcome
clinical pregnancy rate per IUI cycle
Time frame: by ultrasound at ± 5 to 6 weeks after IUI
1 secondary outcome
live birth rate per IUI cycle
Time frame: 40 weeks after IUI
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 19 Oct 2018.
- Derived from this study: PubMed 27565253Peeraer K, D'Hooghe T, Laurent P, Pelckmans S, Delvigne A, Laenen A, Welkenhuysen M, Wyns C, De Neubourg D. Impact of luteal phase support with vaginal progesterone on the clinical pregnancy rate in intrauterine insemination cycles stimulated with gonadotropins: a randomized multicenter study. Fertil Steril. 2016 Nov;106(6):1490-1495. doi: 10.1016/j.fertnstert.2016.07.1096. Epub 2016 Aug 23.
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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 crinone (progesterone 8%, vaginal application) in people with Infertility, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 11 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 19 Oct 2018. 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 Belgium. 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?
clinical pregnancy rate per IUI cycle (time frame: by ultrasound at ± 5 to 6 weeks after IUI). 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 NCT01826747, 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 19 Oct 2018.