Buscopan in Patients Undergoing IVF/Intracytoplasmic Sperm Injection Treatment

March 7, 2024 updated by: Mak Sze Man Jennifer, Chinese University of Hong Kong

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1039

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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®

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: treatment group
20mg Buscopan intravenous will be given 5 minutes prior to embryo transfer
Drug: 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
Other Names:
  • Normal Saline
Placebo Comparator: control group
2ml Normal Saline intravenous will be given 5 minutes prior to embryo transfer
Drug: 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
Other Names:
  • Normal Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
live birth rate
Time Frame: after 24 weeks of gestation
live baby born
after 24 weeks of gestation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
implantation rate
Time Frame: 8-10 days after embryo transfer
positive pregnancy test
8-10 days after embryo transfer
clinical pregnancy rate
Time Frame: at 6 weeks gestation
the presence of at least one gestational sac
at 6 weeks gestation
multiple pregnancy rate
Time Frame: after 24 weeks of gestation
more than 1 live birth
after 24 weeks of gestation
miscarriage rate
Time Frame: before 24 weeks of gestation
biochemical if there is no US evidence of pregnancy and clinical if there is US evidence of pregnancy
before 24 weeks of gestation
ectopic pregnancy rate
Time Frame: at 6-7 weeks of gestation
IU sac out of uterine cavity
at 6-7 weeks of gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: SZE MAN JENNIFER MAK, Chinese University of Hong Kong
  • Principal Investigator: NGA PING PATRICIA IP, Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2020

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

September 14, 2024

Study Registration Dates

First Submitted

January 26, 2021

First Submitted That Met QC Criteria

February 10, 2021

First Posted (Actual)

February 11, 2021

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019.109-T

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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