Buscopan in Patients Undergoing IVF/Intracytoplasmic Sperm Injection Treatment

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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IVF, Intracytoplasmic Sperm Injection

Intervention / Treatment
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* Drug: Buscopan 20 milligrams/ML Injectable Solution


Participation Criteria
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Eligibility Criteria
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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®

Ages Eligible for Study
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Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective double blinded randomized controlled trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: treatment group<br>20mg Buscopan intravenous will be given 5 minutes prior to embryo transfer | Drug: Buscopan 20 milligrams/ML Injectable Solution<br>* cases will be randomized to Buscopan group or Normal Saline group, injection will be given 5 minutes prior to embryo transfer<br>* Other names: Normal Saline;|
| Placebo Comparator: control group<br>2ml Normal Saline intravenous will be given 5 minutes prior to embryo transfer | Drug: Buscopan 20 milligrams/ML Injectable Solution<br>* cases will be randomized to Buscopan group or Normal Saline group, injection will be given 5 minutes prior to embryo transfer<br>* Other names: Normal Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| live birth rate | live baby born | after 24 weeks of gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implantation rate | positive pregnancy test | 8-10 days after embryo transfer | 
| clinical pregnancy rate | the presence of at least one gestational sac | at 6 weeks gestation | 
| multiple pregnancy rate | more than 1 live birth | after 24 weeks of gestation | 
| 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 | 
| ectopic pregnancy rate | IU sac out of uterine cavity | at 6-7 weeks of gestation |