NCT06036459

Brief 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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
117

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2023

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 14, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

2 years

First QC Date

August 13, 2023

Last Update Submit

September 18, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Biochemical pregnancy

    2 weeks after embryo transfer

  • Miscarriage

    From 6 weeks of gestation until 28 weeks of gestation

  • Ectopic pregnancy

    the site of the gestational sac will be assessed 2 weeks after embryo transfer

  • Ongoing pregnancy

    After 12 weeks of gestation until delivery

  • Live birth

    From 28 weeks of gestation until delivery

Interventions

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.

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women undergoing IVF

You may qualify if:

  • 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

You may not qualify if:

  • Women refusing to participate in clinical research.
  • Any uncorrected uterine abnormality, such as septum, myoma, adenomyosis, or polyp
  • Hydrosalpinx without prior disconnection or excision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Study Officials

  • Mahmoud Abdelaziz, M.Sc

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Karim Abdallah, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

August 13, 2023

First Posted

September 14, 2023

Study Start

October 1, 2023

Primary Completion

October 1, 2025

Study Completion

June 1, 2026

Last Updated

September 21, 2023

Record last verified: 2023-09