Buscopan in Patients Undergoing IVF/Intracytoplasmic Sperm Injection Treatment

IVF Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04751084
• Other study ID #: 2019.109-T
• Status: Recruiting
• Phase: N/A
• Start date: May 30, 2020
• Est. completion date: September 14, 2024

Study information

• Verified date: March 2024
• Source: Chinese University of Hong Kong
• Contact: WING IU LI
• Phone: 3505 1764
• Email: wingiuli[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1039
• Est. completion date: September 14, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 42 Years

Eligibility

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®

Related Conditions & MeSH terms

• Intracytoplasmic Sperm Injection
• IVF

Intervention

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

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

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