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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