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InfertilityEPFENCT07358468

Association Between Peri-Transfer Endometrial Peristalsis And Live Birth In Modified Natural Cycle Frozen Embryo Transfer: A Prospective Cohort Study

An observational study of Infertility and Endometrial Peristalsis, run by Mỹ Đức Hospital at 2 sites in Vietnam.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The uterus is a dynamic muscular organ that undergoes rhythmic, wave-like contractions known as endometrial peristalsis or endometrial waves. This muscular activity, which is an essential component of natural fertility, presents a nuanced and sometimes contradictory role in the context of assisted reproductive… Read more about this study

Who is it for?
Ages 18 to 42 years, women only
What is being tested?
Endometrial peristalsis and hormone measurements
Type of treatment
Injection or infusion
How many people
384 participants
Where
2 sitesVietnam
Study dates
22 Feb 2026to 1 Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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 18 to 42 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: Women undergoing frozen embryo transfer during the study period.

Who may be able to join

  • Women aged 18 - 42 years old
  • Scheduled for frozen embryo transfer cycles using hormone replacement therapy protocol or natural cycle protocol (True natural cycles or modified natural cycles)
  • Transferred no more than two cleavage embryos or one good-quality blastocyst or no more than two poor-quality blastocysts

Who cannot join

  • Having an allergy and contraindications for exogenous hormone administration (e.g., breast cancer, thromboembolic disease)
  • Cycles with preimplantation genetic testing, oocyte donation, or in vitro maturation
  • Having untreated uterine or adnexal abnormalities (e.g., intrauterine adhesions, unicornuate/ bicornuate/ arcuate uterus, endometrial polyp, large leiomyoma ≥5 cm in diameter, hydrosalpinx, endometrial hyperplasia).
  • Use of uterine relaxants or intralipid infusion during the embryo transfer process.
  • Use of a GnRH-agonist for downregulation within one month.
  • PCOS patients

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Vietnam2 sites, 2 recruiting
  • My Duc Phu Nhuan Hospital

    Ho Chi Minh City, 70000

    Xuyen TH Le, MD, +84945260494, bsxuyen.lth@myduchospital.vn

    Recruiting
  • IVFMD Phu Nhuan - My Duc Phu Nhuan Hospital

    Ho Chi Minh City

    Not yet recruiting

Other trials in Vietnam

About this study

Official title: Effects Of Modified Natural Cycle Protocol Peristalsis And Live Birth In Frozen Embryo Transfer: A Prospective Cohort Study

The uterus is a dynamic muscular organ that undergoes rhythmic, wave-like contractions known as endometrial peristalsis or endometrial waves. This muscular activity, which is an essential component of natural fertility, presents a nuanced and sometimes contradictory role in the context of assisted reproductive treatments. Endometrial peristalsis refers to the frequency, amplitude, and pattern of myometrial contractions occurring in different reproductive phases. These peristalsis play vital roles in sperm transport, embryo migration, and implantation. Clinical and imaging studies suggest that abnormal patterns or excessive contractility at the time of embryo transfer may disrupt endometrial-embryo synchrony, impair implantation, and increase miscarriage risk. However, most evidence on endometrial peristalsis pertains to fresh embryo transfer cycles, natural conceptions, or pathological contexts, such as adenomyosis or fibroids, with limited insights regarding its effects on different endometrial preparation protocols in frozen embryo transfer (FET). Understanding the dynamics of endometrial peristalsis in this context is clinically important, as inappropriate contractile activity could physically expel the embryo or create a non-receptive environment, ultimately reducing the chances of live birth. Despite its theoretical significance, there is a paucity of robust, prospective data correlating endometrial peristalsis patterns measured around the time of FET with different endometrial preparation protocols with subsequent pregnancy outcomes.

Read the detailed description

The uterus is a dynamic muscular organ that undergoes rhythmic, wave-like contractions known as endometrial peristalsis or endometrial waves. This muscular activity, which is an essential component of natural fertility, presents a nuanced and sometimes contradictory role in the context of assisted reproductive treatments. Endometrial peristalsis refers to the frequency, amplitude, and pattern of myometrial contractions occurring in different reproductive phases. These peristalsis play vital roles in sperm transport, embryo migration, and implantation.

Clinical and imaging studies suggest that abnormal patterns or excessive contractility at the time of embryo transfer may disrupt endometrial-embryo synchrony, impair implantation, and increase miscarriage risk. However, most evidence on uterine contractility pertains to fresh embryo transfer cycles, natural conceptions, or pathological contexts, such as adenomyosis or fibroids, with limited insights regarding its effects on different FET protocols. Several studies have demonstrated an inverse relationship between endometrial peristalsis and IVF success. Masroor et al. found that patients with lower endometrial peristaltic wave frequency (<4 waves/min) before embryo transfer had significantly higher chances of clinical pregnancy and live birth compared to those with more frequent peristalsis. Similarly, Chung et al. reported that increased endometrial peristalsis frequency immediately after embryo transfer was linked to reduced live birth rates, suggesting that excessive motility may physically expel the embryo or disturb its implantation. In the prospective cohort study of 292 infertile women, Zhu et al. found that lower uterine peristaltic wave frequency (<3.0 waves/min) before embryo transfer is associated with higher clinical pregnancy rates in both fresh and frozen-thawed embryo transfer cycles. In a study by Vuong et al. on patients with repeated implantation failure, they found that administering atosiban to patients with uterine peristalsis exceeding 16 waves per 4 minutes could improve pregnancy rates.

In recent years, there has been growing interest in performing FET in natural cycles. Natural-cycle FET protocols may better reproduce physiological endocrine and uterine environments than fully artificial, hormone-replacement cycles, potentially influencing uterine contractility patterns, implantation rates, and obstetric outcomes, while also reducing medication burden for ovulatory women. Building on this evidence, the present study will examine the relationship between peri-transfer uterine peristalsis in natural-cycle frozen embryo transfer and subsequent live birth, with the aim of identifying clinically relevant thresholds of contractile activity that could inform individualized embryo-transfer strategies.

Being tested
Endometrial peristalsis and hormone measurements
Keywords
endometrial peristalsis, uterine contractions, endometrial waves, frozen embryo transfer, natural cycles, artificial cycles
Medical subject headings
Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endometrial peristalsis and hormone measurementsOther

    Time point for measurement

    Endometrial peristalsis will be assessed at three specific time points:

    • On the second day to the fourth day of the menstrual cycle in the FET cycles.
    • The day of hCG trigger, (before progesterone exposure)
    • On the day of embryo transfer, immediately prior to the procedure

    Hormone measurements

    Serum levels of estradiol (E2) and progesterone (P4) will be assessed three times, on the same days as the endometrial peristalsis measurements, using electrochemiluminescence immunoassays. (Elecsys® Estradiol III and Elecsys® Progesterone III, Cobas® e 411, Roche Diagnostics, Germany):

    • On the second day to the fourth day of the menstrual cycle in the FET cycles
    • The day of hCG trigger
    • On the transfer day prior to the procedure.
Study groups in NCT07358468
Study groupRoleWhat they receive
Modified natural cycleOn modified natural cycle, when the mean diameter of the dominant follicle is ≥16 mm, human chorionic gonadotropin (hCG, Ovitrelle® 250 µg; Merck, USA or IVF-C 5000IU, LG Chem, Korea) will be injected to trigger ovulation. Vaginal progesterone (Cyclogest, LD Collins, UK) at a dose of 800 mg per day was started 2 days after hCG injection. Embryo transfer will be scheduled by the time of hCG trigger and embryo stages. Vaginal progesterone administration will be maintained until the day of the pregnancy test. In the event of a positive test result, luteal phase support will be extended until 10 weeks of gestation.
Receives: Other: Endometrial peristalsis and hormone measurements

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The association between live birth and uterine contraction frequency measured at different time points.

    • Live birth was defined as the complete expulsion or extraction from a woman of a product of fertilization, after 22 completed weeks of gestational age; which, after such separation, breathes or shows any other evidence of life, such as heartbeat, umbilical cord pulsation, or definite movement of voluntary muscles, irrespective of whether the umbilical cord has been cut or the placenta is attached. A birth weight of 500 grams or more can be used if gestational age is unknown. Live births refer to the individual newborn; for example, a twin delivery represents two live births.
    • Uterine contraction frequency is defined as the number of peristaltic waves per minute.

    Measured: • On the second day to the fourth day of the menstrual cycle in the FET cycles. • The day of hCG trigger • On the day of embryo transfer, immediately prior to the procedure

Secondary outcomes (26)
  1. The frequency of endometrial peristalsis at different time points

    The frequency of endometrial peristalsis at different time points

    Measured: On the second day to the fourth day of the menstrual cycle in the FET cycles. The day of hCG trigger On the day of embryo transfer, immediately prior to the procedure

  2. Live birth rates after the one embryo transfer.

    Live birth was defined as the complete expulsion or extraction from a woman of a product of fertilization, after 22 completed weeks of gestational age; which, after such separation, breathes or shows any other evidence of life, such as heartbeat, umbilical cord pulsation, or definite movement of voluntary muscles, irrespective of whether the umbilical cord has been cut or the placenta is attached. A birth weight of 500 grams or more can be used if gestational age is unknown. Live births refer to the individual newborn; for example, a twin delivery represents two live births.

    Measured: At delivery

  3. Direction of peristalsis.

    Direction of peristalsis is categorized as cervix-to-fundus, fundus-to-cervix, indeterminate, or absent (no contractions observed)

    Measured: • On the second day to the fourth day of the menstrual cycle in the FET cycles. • The day of progesterone initiation or LH surge/hCG trigger, (before progesterone exposure) • On the day of embryo transfer, immediately prior to the procedure

  4. The correlation between endometrial peristalsis at different time points

    The correlation between endometrial peristalsis at different time points.

    Measured: • On the second day to the fourth day of the menstrual cycle in the FET cycles. • The day of progesterone initiation or LH surge/hCG trigger, (before progesterone exposure) • On the day of embryo transfer, immediately prior to the procedure

  5. Positive pregnancy test

    Defined as serum human chorionic gonadotropin level ≥ 25 mIU/mL.

    Measured: 10-14 days after embryo transfer

  6. Clinical pregnancy

    A pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. In addition to intra-uterine pregnancy, it includes a clinically documented ectopic pregnancy.

    Measured: 4-6 weeks after embryo transfer

  7. Ongoing pregnancy

    A pregnancy diagnosed by ultrasonographic or clinical documentation of at least one fetus with a discernible heartbeat at 12 weeks gestation or beyond.

    Measured: 12 weeks of gestation or beyond

  8. Implantation rate

    The number of gestational sacs observed divided by the number of embryos transferred (usually expressed as a percentage).

    Measured: At 4-6 weeks after embryo transfer

  9. Ectopic pregnancy

    A pregnancy outside the uterine cavity, diagnosed by ultrasound, surgical visualization, or histopathology.

    Measured: Up to 12 weeks after embryo transfer

  10. Miscarriage

    Spontaneous loss of a clinical pregnancy before 22 completed weeks of gestational age, in which the embryo(s) or fetus(es) is/are nonviable and is/are not spontaneously absorbed or expelled from the uterus.

    Measured: Up to 22 weeks of gestation

  11. Multiple gestations

    A pregnancy with more than one embryo or fetus.

    Measured: At delivery

  12. Multiple birth

    The complete expulsion or extraction from a woman of more than one fetus, after 22 completed weeks of gestational age, irrespective of whether it is a live birth or stillbirth. Births refer to the individual newborn; for example, a twin delivery represents two births.

    Measured: At delivery

  13. Mode of delivery

    Vaginal delivery, C-section (elective, suspected fetal distress, non-progressive labor).

    Measured: At delivery

  14. Birth weight

    Weight of the newborn measured right after delivery.

    Measured: At delivery

  15. Gestational age at birth

    Calculated by gestational age of all live births.

    Measured: At delivery

  16. Preterm birth

    Defined as delivery at <28, <32, <37 completed weeks. A birth that takes place after 22 weeks and before 37 completed weeks of gestational age.

    Measured: At delivery

  17. Gestational diabetes mellitus

    A 75-g OGTT, with plasma glucose measurement when the patient is fasting and at 1 and 2 h, at 24-28 weeks of gestation in women not previously diagnosed with diabetes.

    Measured: At 24-28 weeks of gestation

  18. Hypertensive disorders of pregnancy

    Hypertensive disorders of pregnancy: Pregnancy-induced hypertension, pre-eclampsia (early and late), eclampsia, and HELLP syndrome are defined in the American College of Obstetricians and Gynecologists (ACOG) 2020 g

    Measured: Up to delivery

  19. Stillbirth

    The death of a fetus before the complete expulsion or extraction from its mother after 28 completed weeks of gestational age. The death is determined by the fact that, after such separation, the fetus does not breathe or show any other evidence of life, such as heartbeat, umbilical cord pulsation, or definite movement of voluntary muscles. Note: It includes deaths occurring during labor.

    Measured: Up to delivery

  20. Very low birth weight

    Birth weight less than 1.500 g.

    Measured: Up to delivery

  21. Low birth weight

    Birth weight less than 2.500 g.

    Measured: Up to delivery

  22. High birth weight

    Implies growth beyond an absolute birth weight, historically 4.000 g or 4.500 g, regardless of the gestational age.

    Measured: Up to delivery

  23. Very high birth weight

    Birth weight over 4.500 g for women with diabetes, and a threshold of 5000 g for women without diabetes.

    Measured: Up to delivery

  24. Major congenital abnormalities

    Structural, functional, and genetic anomalies that occur during pregnancy, and are identified antenatally, at birth, or later in life, and require surgical repair of a defect, or are visually evident, or life-threatening, or cause death. Any congenital anomaly will be included as follows definition of congenital abnormalities in Surveillance of Congenital Anomalies by Division of Birth Defects and Developmental Disabilities, NCBDDD, Centers for Disease Control and Prevention (2020).

    Measured: Up to delivery

  25. NICU admission

    The admission of the newborn to the NICU.

    Measured: Up to delivery

  26. Neonatal mortality

    Death of a live-born baby within 28 days of birth. This can be divided into early neonatal mortality, if death occurs in the first seven days after birth, and late neonatal if death occurs between 8 and 28 days after delivery.

    Measured: Up to delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2026
  2. Study start22 Feb 2026
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 Dec 2027 (estimated)

Resources

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
384 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07358468
Sponsor's protocol ID
18/25/DD-BVMD
Acronym
EPFE
Status last verified
Mar 2026
First submitted
26 Dec 2025
Last updated
19 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Infertility and Endometrial Peristalsis, run by Mỹ Đức Hospital at 2 sites in Vietnam.

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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xuyen Thi Ha Le, MD (+84945260494, bsxuyen.lth@myduchospital.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The association between live birth and uterine contraction frequency measured at different time points. (time frame: • On the second day to the fourth day of the menstrual cycle in the FET cycles. • The day of hCG trigger • On the day of embryo transfer, immediately prior to the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 19 Aug 2026.

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