Women With Fertility DisorderPhase 4NCT01674283
Effect of Glucagon on Uterine Contractility at the Time of Embryo Transfer in in Vitro Fertilization
A Phase 4 study testing Glucagon in people with Women With Fertility Disorder, run by Clinique Ovo at 1 site in Canada.
Trial summary
The success of in vitro fertilization is based mainly on uterine implantation embryo. An excessive uterine contractility may interfere with implantation by a movement of the embryo in the uterus. The inhibition of the uterine contractility may have a positive effect on success rate of in vitro fertilization. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Women With Fertility Disorder
- What is being tested?
- Glucagon
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2013to Oct 2013
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women doing fertility treatment at the clinic ovo or fertility clinic of CHUM
- Less than 40 years old
- Women with stimulate in vitro fertilization cycle
- Women able to give her consent
Who cannot join
- Body mass index > 35 kg/m2
- Women with diabetes
- Women with hypertensive disorders
- Women with a blood pressure greater or equal to 140/90 mmHg at the randomization visit
- Cons-indication to taking Glucagon:
- Hypersensitivity to product
Show all 9Show fewer
- Pheochromocytoma or history of pheochromocytoma
- Insulinoma
- Taking a beta-blocker (drug interactions)
Trial locations and contacts
1 site in 1 country.
About this study
The success of in vitro fertilization is based mainly on uterine implantation embryo. An excessive uterine contractility may interfere with implantation by a movement of the embryo in the uterus. The inhibition of the uterine contractility may have a positive effect on success rate of in vitro fertilization. It is through parenteral injection of glucagon and its spasmolytic effect on various smooth muscles and thereby on the uterine muscle, at the time of embryo transfer, the investigators intend to improve the pregnancy rates obtained after IVF.
Read the detailed description
Women will have a cycle of in vitro fertilization (IVF) and follow the standard protocol established by the clinic ovo or the fertility clinic of CHUM. On the day of embryo transfer, the investigators will administer 1 mg of Glucagon or placebo intramuscularly 10 minutes before the embryo transfer. The uterine contractility will be measured by ultrasound before and after injection to document the impact of Glucagon on it and we will proceed to embryo transfer.
- Conditions
- Women With Fertility Disorder
- Being tested
- Glucagon, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucagonDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Glucagon | Experimental | The first recording is a transvaginal ultrasound in midsagittale position for the measurement of the basic uterine contractility 2 minutes before the injection of Glucagon.
The second recording is doing the same way 10 minutes after the Glucagon injection, just before the embryo transfer. Receives: Drug: Glucagon |
| Sodium chloride 0.9% | Placebo comparator | The first recording is a transvaginal ultrasound in midsagittale position for the measurement of the basic uterine contractility 2 minutes before the injection of the placebo.
The second recording is doing the same way 10 minutes after the placebo injection, just before the embryo transfer. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uterine muscle relaxation
Determine if the intramuscular administration of 1mg of Glucagon 10 minutes before the embryo transfer is associated with a uterine muscle relaxation.
Measured: 30 minutes
Secondary outcomes (1)
Embryo implantation and pregnancy rate
Determine if the intramuscular administration of 1mg of Glucagon 10 minutes before the embryo transfer is associated with higher implantation and pregnancy rates than during embryo transfer without glucagon.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2012 (estimated)
- Study startOct 2013
- Primary completionOct 2013
- Study completionOct 2013
Why it stopped: Uterine contractility not possible to visualize with our ultrasound machines
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women With Fertility DisorderStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Ovo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Himaya, Dr, Principal investigator, clinique ovo and CHUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01674283
- Sponsor's protocol ID
- OVO-12-08
- Status last verified
- Jul 2015
- First submitted
- 23 Aug 2012
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Glucagon on Uterine Contractility at the Time of Embryo Transfer in in Vitro Fertilization
- ClinicalTrials.gov ID
- NCT01674283
- Acronym / sponsor ID
- OVO-12-08
- Conditions
- Women With Fertility Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Uterine contractility not possible to visualize with our ultrasound machines
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Clinique OvoIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 28 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 success of in vitro fertilization is based mainly on uterine implantation embryo. An excessive uterine contractility may interfere with implantation by a movement of the embryo in the uterus. The inhibition of the uterine contractility may have a positive effect on success rate of in vitro fertilization. It is through parenteral injection of glucagon and its spasmolytic effect on various smooth muscles and thereby on the uterine muscle, at the time of embryo transfer, the investigators intend to improve the pregnancy rates obtained after IVF.
Detailed description
Women will have a cycle of in vitro fertilization (IVF) and follow the standard protocol established by the clinic ovo or the fertility clinic of CHUM. On the day of embryo transfer, the investigators will administer 1 mg of Glucagon or placebo intramuscularly 10 minutes before the embryo transfer. The uterine contractility will be measured by ultrasound before and after injection to document the impact of Glucagon on it and we will proceed to embryo transfer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glucagon | Experimental | Drug: GlucagonThe first recording is a transvaginal ultrasound in midsagittale position for the measurement of the basic uterine contractility 2 minutes before the injection of Glucagon. The second recording is doing the same way 10 minutes after the Glucagon injection, just before the embryo transfer. |
| Sodium chloride 0.9% | Placebo comparator | Drug: placeboThe first recording is a transvaginal ultrasound in midsagittale position for the measurement of the basic uterine contractility 2 minutes before the injection of the placebo. The second recording is doing the same way 10 minutes after the placebo injection, just before the embryo transfer. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women doing fertility treatment at the clinic ovo or fertility clinic of CHUM
- Less than 40 years old
- Women with stimulate in vitro fertilization cycle
- Women able to give her consent
Key exclusion criteria (9 listed)
- Body mass index > 35 kg/m2
- Women with diabetes
- Women with hypertensive disorders
- Women with a blood pressure greater or equal to 140/90 mmHg at the randomization visit
- Cons-indication to taking Glucagon:
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 |
|---|---|---|
| Glucagon | Drug | Glucagon |
| placebo | Drug | Sodium chloride 0.9% |
Primary outcome
Uterine muscle relaxation
Time frame: 30 minutes
Determine if the intramuscular administration of 1mg of Glucagon 10 minutes before the embryo transfer is associated with a uterine muscle relaxation.
1 secondary outcome
Embryo implantation and pregnancy rate
Time frame: 7 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
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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.
Eric Himaya, Dr principal investigator
clinique ovo and CHUM
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 Glucagon in people with Women With Fertility Disorder, run by Clinique Ovo at 1 site in Canada.
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 4 inclusion and 9 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: withdrawn, as of the sponsor's last update on 28 Jul 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 Canada. 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 was withdrawn before enrolling participants, so there are no results.
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?
Uterine muscle relaxation (time frame: 30 minutes). 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 28 Jul 2015.