Buscopan in Patients Undergoing IVF/Intracytoplasmic Sperm Injection Treatment

NCT ID: NCT04751084

Last Updated: 2024-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

675 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-30

Study Completion Date

2024-09-14

Brief Summary

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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.

Detailed Description

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Conditions

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IVF Intracytoplasmic Sperm Injection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A prospective double blinded randomized controlled trial
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
double blinded to the randomization list

Study Groups

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treatment group

20mg Buscopan intravenous will be given 5 minutes prior to embryo transfer

Group Type ACTIVE_COMPARATOR

Buscopan 20 milligrams/ML Injectable Solution

Intervention Type DRUG

cases will be randomized to Buscopan group or Normal Saline group, injection will be given 5 minutes prior to embryo transfer

control group

2ml Normal Saline intravenous will be given 5 minutes prior to embryo transfer

Group Type PLACEBO_COMPARATOR

Buscopan 20 milligrams/ML Injectable Solution

Intervention Type DRUG

cases will be randomized to Buscopan group or Normal Saline group, injection will be given 5 minutes prior to embryo transfer

Interventions

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Buscopan 20 milligrams/ML Injectable Solution

cases will be randomized to Buscopan group or Normal Saline group, injection will be given 5 minutes prior to embryo transfer

Intervention Type DRUG

Other Intervention Names

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Normal Saline

Eligibility Criteria

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Inclusion Criteria

\- Women undergoing embryo transfer in either fresh or frozen cycles

Exclusion Criteria

* 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
* 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®
Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Mak Sze Man Jennifer

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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SZE MAN JENNIFER MAK

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

NGA PING PATRICIA IP

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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Prince of Wales Hospital

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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2019.109-T

Identifier Type: -

Identifier Source: org_study_id

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