Buscopan in Patients Undergoing IVF/Intracytoplasmic Sperm Injection Treatment
Overview
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.
Full Title of Study: “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”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Prevention
- Masking: Triple (Participant, Care Provider, Investigator)
- Study Primary Completion Date: April 30, 2024
Interventions
- 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
Arms, Groups and Cohorts
- Active Comparator: treatment group
- 20mg Buscopan intravenous will be given 5 minutes prior to embryo transfer
- Placebo Comparator: control group
- 2ml Normal Saline intravenous will be given 5 minutes prior to embryo transfer
Clinical Trial Outcome Measures
Primary Measures
- live birth rate
- Time Frame: after 24 weeks of gestation
- live baby born
Secondary Measures
- implantation rate
- Time Frame: 8-10 days after embryo transfer
- positive pregnancy test
- clinical pregnancy rate
- Time Frame: at 6 weeks gestation
- the presence of at least one gestational sac
- multiple pregnancy rate
- Time Frame: after 24 weeks of gestation
- more than 1 live birth
- 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
- ectopic pregnancy rate
- Time Frame: at 6-7 weeks of gestation
- IU sac out of uterine cavity
Participating in This Clinical Trial
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®
Gender Eligibility: Female
aged <42 years old
Minimum Age: N/A
Maximum Age: 42 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Chinese University of Hong Kong
- Provider of Information About this Clinical Study
- Principal Investigator: Mak Sze Man Jennifer, Associate Professor – Chinese University of Hong Kong
- Overall Official(s)
- SZE MAN JENNIFER MAK, Principal Investigator, Chinese University of Hong Kong
- NGA PING PATRICIA IP, Principal Investigator, Chinese University of Hong Kong
- Overall Contact(s)
- WING IU LI, 3505 1764, wingiuli@cuhk.edu.hk
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