IVFNCT04751084
Buscopan in Patients Undergoing IVF/Intracytoplasmic Sperm Injection Treatment
A study testing Buscopan 20 milligrams/ML Injectable Solution in people with IVF and Intracytoplasmic Sperm Injection, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
To determine if the use of Buscopan in patients undergoing IVF/ICSI treatment with high uterine contraction frequency prior to embryo transfer has a higher live birth rate. Read more about this study
- Who is it for?
- Ages Up to 42 years, women only
- Conditions the study is for
- IVF, Intracytoplasmic Sperm Injection
- What is being tested?
- Buscopan 20 milligrams/ML Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 675 participants
- Where
- 1 siteHong Kong
- Study dates
- 30 May 2020to 14 Sep 2024
- 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 Up to 42 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Women undergoing embryo transfer in either fresh or frozen cycles
Who cannot join
- Women aged > 42 years old
- Women with factors which will affect uterine contractility
- congenital uterine anomaly
- acquired uterine pathology such as myoma >5cm, adenomyosis >5cm or endometrial polyp
- Women with presence of hydrosalpinx
- Women undergoing pre-implantation genetic test in IVF cycles
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- History of allergy to misoprostol , Buscopan® or same group of drug
- Contraindication to the use of Buscopan® e.g. glaucoma, myasthenia gravis, tachycardia, megacolon
- Women who are on other smooth muscle relaxant other than Buscopan®
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Buscopan in Patients Undergoing IVF/Intracytoplasmic Sperm Injection Treatment With High and Low Uterine Contraction Frequency Prior to Embryo Transfer: A Prospective Double-blinded Randomized Controlled Trial
To determine if the use of Buscopan in patients undergoing IVF/ICSI treatment with high uterine contraction frequency prior to embryo transfer has a higher live birth rate.
- Conditions
- IVF, Intracytoplasmic Sperm Injection
- Being tested
- Buscopan 20 milligrams/ML Injectable Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buscopan 20 milligrams/ML Injectable SolutionDrug
Also called Normal Saline
cases will be randomized to Buscopan group or Normal Saline group, injection will be given 5 minutes prior to embryo transfer
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Active comparator | 20mg Buscopan intravenous will be given 5 minutes prior to embryo transfer Receives: Drug: Buscopan 20 milligrams/ML Injectable Solution |
| control group | Placebo comparator | 2ml Normal Saline intravenous will be given 5 minutes prior to embryo transfer Receives: Drug: Buscopan 20 milligrams/ML Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
live birth rate
live baby born
Measured: after 24 weeks of gestation
Secondary outcomes (5)
implantation rate
positive pregnancy test
Measured: 8-10 days after embryo transfer
clinical pregnancy rate
the presence of at least one gestational sac
Measured: at 6 weeks gestation
multiple pregnancy rate
more than 1 live birth
Measured: after 24 weeks of gestation
miscarriage rate
biochemical if there is no US evidence of pregnancy and clinical if there is US evidence of pregnancy
Measured: before 24 weeks of gestation
ectopic pregnancy rate
IU sac out of uterine cavity
Measured: at 6-7 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start30 May 2020
- Primary completion30 Apr 2024
- Study completion14 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IVFStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective double blinded randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 675 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mak Sze Man Jennifer, Chinese University of Hong Kong
- Investigators
- SZE MAN JENNIFER MAK, Principal investigator, Chinese University of Hong KongNGA PING PATRICIA IP, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04751084
- Sponsor's protocol ID
- 2019.109-T
- Status last verified
- May 2024
- First submitted
- 26 Jan 2021
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Buscopan in Patients Undergoing IVF/Intracytoplasmic Sperm Injection Treatment With High and Low Uterine Contraction Frequency Prior to Embryo Transfer: A Prospective Double-blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04751084
- Acronym / sponsor ID
- 2019.109-T
- Conditions
- IVF, Intracytoplasmic Sperm Injection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 675 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 30 May 2020 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 14 Sep 2024 (estimated)
- First posted
- 11 Feb 2021 (actual)
- 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.
To determine if the use of Buscopan in patients undergoing IVF/ICSI treatment with high uterine contraction frequency prior to embryo transfer has a higher live birth rate.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- A prospective double blinded randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| treatment group | Active comparator | Drug: Buscopan 20 milligrams/ML Injectable Solution20mg Buscopan intravenous will be given 5 minutes prior to embryo transfer |
| control group | Placebo comparator | Drug: Buscopan 20 milligrams/ML Injectable Solution2ml Normal Saline intravenous will be given 5 minutes prior to embryo transfer |
Who may qualify
- Ages
- Up to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Women undergoing embryo transfer in either fresh or frozen cycles
Key exclusion criteria (9 listed)
- Women aged > 42 years old
- Women with factors which will affect uterine contractility
- congenital uterine anomaly
- acquired uterine pathology such as myoma >5cm, adenomyosis >5cm or endometrial polyp
- Women with presence of hydrosalpinx
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 |
|---|---|---|
| Buscopan 20 milligrams/ML Injectable SolutionAlso: Normal Salinecases will be randomized to Buscopan group or Normal Saline group, injection will be given 5 minutes prior to embryo transfer | Drug | control group, treatment group |
Primary outcome
live birth rate
Time frame: after 24 weeks of gestation
live baby born
5 secondary outcomes
implantation rate
Time frame: 8-10 days after embryo transfer
clinical pregnancy rate
Time frame: at 6 weeks gestation
multiple pregnancy rate
Time frame: after 24 weeks of gestation
miscarriage rate
Time frame: before 24 weeks of gestation
ectopic pregnancy rate
Time frame: at 6-7 weeks of gestation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
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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.
SZE MAN JENNIFER MAK principal investigator
Chinese University of Hong Kong
NGA PING PATRICIA IP principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buscopan 20 milligrams/ML Injectable Solution in people with IVF and Intracytoplasmic Sperm Injection, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 1 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: status not confirmed, as of the sponsor's last update on 8 May 2024. 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 Hong Kong. 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.
Are results available for this study?
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?
live birth rate (time frame: after 24 weeks of gestation). 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 8 May 2024.