Uterine Peristalsis in IVF

Infertility, Female Clinical Trial

Official title:

Effect of Uterine Peristalsis at the Time of Embryo Transfer on the Outcomes of IVF Cycles: a Prospective Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06036459
• Other study ID #: Uterine Peristalsis in IVF
• Status: Not yet recruiting
• Start date: October 2023
• Est. completion date: June 2026

Study information

• Verified date: September 2023
• Source: Assiut University
• Contact: Karim Abdallah, MD
• Phone: +201270595485
• Email: karimsayed88[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

An observational prospective cohort study to evaluate the effect of uterine peristalsis at the time of embryo transfer on IVF clinical outcomes performed in Women's Health hospital, Assiut University, Egypt.

Women performing fresh or frozen embryo transfer who do not have any uterine abnormalities will be included in the study

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 117
• Est. completion date: June 2026
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• • Women undergoing embryo transfer during IVF cycles.

• Age: between 20 and 40 years.

• Have at least 1 good quality embryo at the time of transfer

• Fresh or frozen-thawed cycles.

• Any stimulation protocol in fresh cycles, or any endometrial preparation protocol for frozen-thawed cycles

Exclusion Criteria:

• • Women refusing to participate in clinical research.

• Any uncorrected uterine abnormality, such as septum, myoma, adenomyosis, or polyp

• Hydrosalpinx without prior disconnection or excision

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Other:
• uterine peristalsis
Transabdominal us followed by Transvaginal ultrasonography scans (Sono Ace R5 ) of uterine peristalsis will performed on the day of embryo transfer while the patient lying relaxed in lithotomy position. The probe will be introduced into the vagina as gently as possible to avoid stimulating the cervix. After scanning the mid-sagittal plane of the uterus, the probe will be fixed as steady as possible while a 3 min video of uterine peristalsis will be recorded simultaneously. The records will be analyzed at 4X regular speed using a Video player application by two independent experienced observers. The uterine peristaltic wave frequency will be the mean of the results from each observer.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy	The presence of intrauterine gestational sac and fetal pole with positive cardiac pulsation by transvaginal ultrasound	2 weeks after a positive pregnancy test
Secondary	Biochemical pregnancy	a positive serum human chorionic gonadotropin	2 weeks after embryo transfer
Secondary	Miscarriage	Pregnancy loss either loss of cardiac pulsation by ultrasound, or spontaneous loss of pregnancy vaginally	From 6 weeks of gestation until 28 weeks of gestation
Secondary	Ectopic pregnancy	Pregnancy outside the uterine cavity	the site of the gestational sac will be assessed 2 weeks after embryo transfer
Secondary	Ongoing pregnancy	The presence of a viable pregnancy after 12 weeks of gestation	After 12 weeks of gestation until delivery
Secondary	Live birth	Delivery of a living foetus after the age of viability	From 28 weeks of gestation until delivery