Uterine Peristalsis in IVF

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06036459

Collaborator

(none)

117

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Infertility, Female	Other: uterine peristalsis

Study Design

Study Type:

Observational

Anticipated Enrollment :

117 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2025

Anticipated Study Completion Date :

Jun 1, 2026

Outcome Measures

Primary Outcome Measures

Clinical pregnancy [2 weeks after a positive pregnancy test]
The presence of intrauterine gestational sac and fetal pole with positive cardiac pulsation by transvaginal ultrasound

Secondary Outcome Measures

Biochemical pregnancy [2 weeks after embryo transfer]
a positive serum human chorionic gonadotropin
Miscarriage [From 6 weeks of gestation until 28 weeks of gestation]
Pregnancy loss either loss of cardiac pulsation by ultrasound, or spontaneous loss of pregnancy vaginally
Ectopic pregnancy [the site of the gestational sac will be assessed 2 weeks after embryo transfer]
Pregnancy outside the uterine cavity
Ongoing pregnancy [After 12 weeks of gestation until delivery]
The presence of a viable pregnancy after 12 weeks of gestation
Live birth [From 28 weeks of gestation until delivery]
Delivery of a living foetus after the age of viability

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

Study Director: Mahmoud Abdelaziz, M.Sc, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Karim Abdallah, Principle investigator, Assiut University

ClinicalTrials.gov Identifier:

NCT06036459

Other Study ID Numbers:

Uterine Peristalsis in IVF

First Posted:

Sep 14, 2023

Last Update Posted:

Sep 21, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infertility

Infertility, Female

Study Results

No Results Posted as of Sep 21, 2023