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Buscopan in Patients Undergoing IVF/Intracytoplasmic Sperm Injection Treatment

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ClinicalTrials.gov Identifier: NCT04751084
Recruitment Status : Recruiting
First Posted : February 11, 2021
Last Update Posted : February 11, 2021
Sponsor:
Information provided by (Responsible Party):
Mak Sze Man Jennifer, 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.

Condition or disease Intervention/treatment Phase
IVF Intracytoplasmic Sperm Injection Drug: Buscopan 20 milligrams/ML Injectable Solution Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A prospective double blinded randomized controlled trial
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: double blinded to the randomization list
Primary Purpose: Prevention
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
Actual Study Start Date : May 30, 2020
Estimated Primary Completion Date : April 29, 2023
Estimated Study Completion Date : April 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: treatment group
20mg Buscopan intravenous will be given 5 minutes prior to embryo transfer
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
Other Name: Normal Saline

Placebo Comparator: control group
2ml Normal Saline intravenous will be given 5 minutes prior to embryo transfer
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
Other Name: Normal Saline




Primary Outcome Measures :
  1. live birth rate [ Time Frame: after 24 weeks of gestation ]
    live baby born


Secondary Outcome Measures :
  1. implantation rate [ Time Frame: 8-10 days after embryo transfer ]
    positive pregnancy test

  2. clinical pregnancy rate [ Time Frame: at 6 weeks gestation ]
    the presence of at least one gestational sac

  3. multiple pregnancy rate [ Time Frame: after 24 weeks of gestation ]
    more than 1 live birth

  4. 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

  5. ectopic pregnancy rate [ Time Frame: at 6-7 weeks of gestation ]
    IU sac out of uterine cavity



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Ages Eligible for Study:   up to 42 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   aged <42 years old
Accepts Healthy Volunteers:   No
Criteria

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®

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04751084


Contacts
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Contact: Sandy Yun Sang Yiu 3505 1764 sandyyiu@cuhk.edu.hk

Locations
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Hong Kong
Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong
Contact: Sandy Yun Sang Yiu    3505 1764    sandyyiu@cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
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Responsible Party: Mak Sze Man Jennifer, Assistant professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT04751084    
Other Study ID Numbers: 2019.109-T
First Posted: February 11, 2021    Key Record Dates
Last Update Posted: February 11, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Butylscopolammonium Bromide
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action