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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04751084
Other study ID # 2019.109-T
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 30, 2020
Est. completion date September 14, 2024

Study information

Verified date May 2024
Source Chinese University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
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 Active, not recruiting
Enrollment 675
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®

Study Design


Related Conditions & MeSH terms


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
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