Buscopan in Patients Undergoing IVF/Intracytoplasmic Sperm Injection Treatment

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

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04751084

Enrollment

675

Registered

2021-02-11

Start date

2020-05-30

Completion date

2024-09-14

Last updated

2024-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracytoplasmic Sperm Injection, IVF

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.

Interventions

DRUGBuscopan 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Masking description

double blinded to the randomization list

Intervention model description

A prospective double blinded randomized controlled trial

Eligibility

Sex/Gender

FEMALE

Age

No minimum to 42 Years

Healthy volunteers

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®

Design outcomes

Primary

Measure	Time frame	Description
live birth rate	after 24 weeks of gestation	live baby born

Secondary

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

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026