NCT04751084

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
675

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 30, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 11, 2021

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2024

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

3.9 years

First QC Date

January 26, 2021

Last Update Submit

May 7, 2024

Conditions

IVFIntracytoplasmic Sperm Injection

Outcome Measures

Primary Outcomes (1)

  • live birth rate

    live baby born

    after 24 weeks of gestation

Secondary Outcomes (5)

  • implantation rate

    8-10 days after embryo transfer

  • clinical pregnancy rate

    at 6 weeks gestation

  • multiple pregnancy rate

    after 24 weeks of gestation

  • miscarriage rate

    before 24 weeks of gestation

  • ectopic pregnancy rate

    at 6-7 weeks of gestation

Study Arms (2)

treatment group

ACTIVE COMPARATOR

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

Drug: Buscopan 20 milligrams/ML Injectable Solution

control group

PLACEBO COMPARATOR

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

Drug: Buscopan 20 milligrams/ML Injectable Solution

Interventions

Buscopan 20 milligrams/ML Injectable SolutionDRUG

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

Also known as: Normal Saline
control grouptreatment group

Eligibility Criteria

AgeUp to 42 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsaged \<42 years old
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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®

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • SZE MAN JENNIFER MAK

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

  • NGA PING PATRICIA IP

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
double blinded to the randomization list
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A prospective double blinded randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 26, 2021

First Posted

February 11, 2021

Study Start

May 30, 2020

Primary Completion

April 30, 2024

Study Completion

September 14, 2024

Last Updated

May 8, 2024

Record last verified: 2024-05

Locations

HK(1)