Buscopan in Patients Undergoing IVF/Intracytoplasmic Sperm Injection Treatment

Not Applicable

Active, not recruiting

• Conditions: IVF; Intracytoplasmic Sperm Injection
• Interventions: Drug: Buscopan 20 milligrams/ML Injectable Solution

• Registration Number: NCT04751084
• Lead Sponsor: Chinese University of Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-30
• Study First Submitted: 2021-01-26
• Study First Submitted QC: 2021-02-10
• Study First Posted: 2021-02-11
• Primary Completion: 2024-04-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08
• Study Completion: 2024-09-14

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 675

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treatment group	Buscopan 20 milligrams/ML Injectable Solution	20mg Buscopan intravenous will be given 5 minutes prior to embryo transfer
control group	Buscopan 20 milligrams/ML Injectable Solution	2ml Normal Saline intravenous will be given 5 minutes prior to embryo transfer

Primary Outcome Measures

Name	Time	Method
live birth rate	after 24 weeks of gestation	live baby born

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong