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
Verified date | May 2024 |
Source | Chinese University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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® |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Prince of Wales Hospital | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
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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