SubfertilityNCT00700492
Does Hormonal Luteal Support After Intra-uterine Insemination (IUI) Increase the Pregnancy Rate?
A study testing progesterone in people with Subfertility, run by University Hospital, Gasthuisberg at 1 site in Belgium.
Trial summary
A randomized study to investigate if hormonal luteal support after intra-uterine insemination (IUI) in ovulation induction cycles with human menopausal gonadotropin increases the pregnancy rate Read more about this study
- Who is it for?
- Ages 18 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Subfertility
- What is being tested?
- progesterone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteBelgium
- Study dates
- May 2004to Jun 2008
- 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 43 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent
- Tubal patency demonstrated
- ovulation induction with human menopausal gonadotropin
Who cannot join
- ovulation induction with clomiphene citrate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Luteal Support With Vaginal Progesterone Capsules Following Ovulation Induction With Human Menopausal Gonadotropins (hMG) for Intra Uterine Insemination: A Comparative Study
A randomized study to investigate if hormonal luteal support after intra-uterine insemination (IUI) in ovulation induction cycles with human menopausal gonadotropin increases the pregnancy rate
- Conditions
- Subfertility
- Being tested
- progesterone
- Keywords
- subfertility, pregnancy rate, miscarriage
- Medical subject headings
- Infertility, Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
progesteroneDrug
Also called Utrogestan
vaginal capsules 3X200mg daily
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Not described |
| utrogestan | Experimental | daily use of vaginal progesterone capsules Receives: Drug: progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy rate per cycle
Measured: 12 weeks pregnancy
Secondary outcomes (1)
rate of miscarriages per cycle
Measured: 12 weeks pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startMay 2004
- Primary completionMar 2008
- Study completionJun 2008
Why it stopped: Change in Belgian law on the use of hMG in IUI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SubfertilityStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gasthuisberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas D'Hooghe, University Hospital, Gasthuisberg
- Investigators
- Thomad D'Hooghe, MD, PhD, Principal investigator, University Hospital Gasthuisberg, Catholic University Leuven, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00700492
- Sponsor's protocol ID
- ML2437-30/12/2003
- Status last verified
- Jun 2015
- First submitted
- 17 Jun 2008
- Last updated
- 25 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Luteal Support With Vaginal Progesterone Capsules Following Ovulation Induction With Human Menopausal Gonadotropins (hMG) for Intra Uterine Insemination: A Comparative Study
- ClinicalTrials.gov ID
- NCT00700492
- Acronym / sponsor ID
- ML2437-30/12/2003
- Conditions
- Subfertility
- Keywords
- subfertility, pregnancy rate, miscarriage
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in Belgian law on the use of hMG in IUI
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University Hospital, GasthuisbergUniversity, hospital or other
- Study start
- May 2004
- Primary completion
- Mar 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 18 Jun 2008 (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.
A randomized study to investigate if hormonal luteal support after intra-uterine insemination (IUI) in ovulation induction cycles with human menopausal gonadotropin increases the pregnancy rate
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | – |
| utrogestan | Experimental | Drug: progesteronedaily use of vaginal progesterone capsules |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Signed informed consent
- Tubal patency demonstrated
- ovulation induction with human menopausal gonadotropin
Key exclusion criteria (1 listed)
- ovulation induction with clomiphene citrate
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 |
|---|---|---|
| progesteroneAlso: Utrogestanvaginal capsules 3X200mg daily | Drug | utrogestan |
Primary outcome
clinical pregnancy rate per cycle
Time frame: 12 weeks pregnancy
1 secondary outcome
rate of miscarriages per cycle
Time frame: 12 weeks pregnancy
Results and safety
The study was stopped early (reason given: Change in Belgian law on the use of hMG in IUI). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2015.
Related trials for Subfertility
RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Adenomyosis of Uterus
Not yet recruitingPhase 3
Progesterone Luteal Support in Unexplained Infertility Management
Infertility, Female Infertility
RecruitingObservational study
Assessing the Correlation Between Phospholipase C Zeta Measurements and Semen Parameters
Male Infertility, Male Subfertility
RecruitingPhase 3
GnRH Agonist for Dual Trigger in IVF and for Luteal Phase Support in FET
Subfertility
RecruitingObservational study
The FLORA-project: in Search for the Microbial Cause of Chronic Endometritis and the Most Appropriate Treatment to Obtain a Successful Pregnancy IVF/ICSI
Endometritis; Chronic, Subfertility
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.
Thomad D'Hooghe, MD, PhD principal investigator
University Hospital Gasthuisberg, Catholic University Leuven, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing progesterone in people with Subfertility, run by University Hospital, Gasthuisberg 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 3 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: stopped early, as of the sponsor's last update on 25 Jun 2015. 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.
Are results available for this study?
The study was stopped early (reason given: Change in Belgian law on the use of hMG in IUI). 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?
clinical pregnancy rate per cycle (time frame: 12 weeks pregnancy). 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 25 Jun 2015.