Infertility, FemaleNCT06036459
Uterine Peristalsis in IVF
An observational study of Infertility, Female, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- uterine peristalsis
- How many people
- 117 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Women undergoing IVF
Who may be able to join
- • 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
Who cannot join
- • Women refusing to participate in clinical research.
- Any uncorrected uterine abnormality, such as septum, myoma, adenomyosis, or polyp
- Hydrosalpinx without prior disconnection or excision
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Uterine Peristalsis at the Time of Embryo Transfer on the Outcomes of IVF Cycles: a Prospective Cohort Study
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
- Conditions
- Infertility, Female
- Being tested
- uterine peristalsis
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uterine peristalsisOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy
The presence of intrauterine gestational sac and fetal pole with positive cardiac pulsation by transvaginal ultrasound
Measured: 2 weeks after a positive pregnancy test
Secondary outcomes (5)
Biochemical pregnancy
a positive serum human chorionic gonadotropin
Measured: 2 weeks after embryo transfer
Miscarriage
Pregnancy loss either loss of cardiac pulsation by ultrasound, or spontaneous loss of pregnancy vaginally
Measured: From 6 weeks of gestation until 28 weeks of gestation
Ectopic pregnancy
Pregnancy outside the uterine cavity
Measured: the site of the gestational sac will be assessed 2 weeks after embryo transfer
Ongoing pregnancy
The presence of a viable pregnancy after 12 weeks of gestation
Measured: After 12 weeks of gestation until delivery
Live birth
Delivery of a living foetus after the age of viability
Measured: From 28 weeks of gestation until delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study startOct 2023 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karim Abdallah, Assiut University
- Investigators
- Mahmoud Abdelaziz, M.Sc, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036459
- Sponsor's protocol ID
- Uterine Peristalsis in IVF
- Status last verified
- Sep 2023
- First submitted
- 13 Aug 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Abdallah KS, Zahran KM, Othman MA, Nasr A. Effect of uterine peristalsis at the time of embryo transfer on the outcomes of IVF cycles: a prospective cohort study. Reprod Biol Endocrinol. 2026 Jul 9;24(1):72. doi: 10.1186/s12958-026-01587-0.
PubMed 42426794
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Uterine Peristalsis at the Time of Embryo Transfer on the Outcomes of IVF Cycles: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06036459
- Acronym / sponsor ID
- Uterine Peristalsis in IVF
- Conditions
- Infertility, Female
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women undergoing IVF
Key inclusion criteria (5 listed)
- • Women undergoing embryo transfer during IVF cycles.
Key exclusion criteria (3 listed)
- • Women refusing to participate in clinical research.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| uterine peristalsisTransabdominal 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. | Other | – |
Primary outcome
Clinical pregnancy
Time frame: 2 weeks after a positive pregnancy test
The presence of intrauterine gestational sac and fetal pole with positive cardiac pulsation by transvaginal ultrasound
5 secondary outcomes
Biochemical pregnancy
Time frame: 2 weeks after embryo transfer
Miscarriage
Time frame: From 6 weeks of gestation until 28 weeks of gestation
Ectopic pregnancy
Time frame: the site of the gestational sac will be assessed 2 weeks after embryo transfer
Ongoing pregnancy
Time frame: After 12 weeks of gestation until delivery
Live birth
Time frame: From 28 weeks of gestation until delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Derived from this study: PubMed 42426794Abdallah KS, Zahran KM, Othman MA, Nasr A. Effect of uterine peristalsis at the time of embryo transfer on the outcomes of IVF cycles: a prospective cohort study. Reprod Biol Endocrinol. 2026 Jul 9;24(1):72. doi: 10.1186/s12958-026-01587-0.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud Abdelaziz, M.Sc study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karim Abdallah, MD (+201270595485, karimsayed88@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy (time frame: 2 weeks after a positive pregnancy test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06036459, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023; AzTrials last refreshed its copy on 4 Nov 2026.