InfertilityCONCONCT07675213
Endometrial Peristalsis and Pregnancy Outcomes in Hormone Replacement Therapy (HRT) - Frozen Embryo Transfer (FET) Cycles
An observational study of Infertility and Endometrial Peristalsis, run by Mỹ Đức Hospital at 1 site in Vietnam.
Trial summary
Endometrial peristalsis may influence embryo implantation and pregnancy outcomes, but its role during hormone replacement therapy (HRT)-prepared frozen embryo transfer (FET) cycles remains unclear. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Infertility, Endometrial Peristalsis, Uterine Contraction
- What is being tested?
- Endometrial peristalsis and hormone measurements
- Type of treatment
- Pill or oral medicine
- How many people
- 442 participants
- Where
- 1 siteVietnam
- Study dates
- 30 Jun 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 hormone replacement therapy 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
- Transferred no more than two cleavage embryos or one good-quality blastocyst or no more than two poor-quality blastocysts
- Provision of written informed consent to participate
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
IVFMD - My Duc Hospital
Ho Chi Minh City, 70000
Nhi NL Ho, MD, +84903497611, drnhiho@gmail.com
Vu NA Ho, MD, PhD, +84 935843336, bsvu.hna@myduchospital.vn
About this study
Official title: Correlation Between Endometrial Peristalsis And Pregnancy Outcomes In Patients Undergoing Frozen Embryo Transfer With Hormone Replacement Therapy for Endometrial Preparation Protocol
Endometrial peristalsis may influence embryo implantation and pregnancy outcomes, but its role during hormone replacement therapy (HRT)-prepared frozen embryo transfer (FET) cycles remains unclear. This prospective observational study will assess endometrial peristalsis at predefined time points during HRT-prepared FET cycles using transvaginal ultrasonography and evaluate its association with pregnancy outcomes. The study aims to clarify the clinical significance of endometrial peristalsis in HRT-prepared FET cycles and to provide evidence supporting endometrial assessment in assisted reproductive technology.
Read the detailed description
Frozen embryo transfer (FET) has become an integral component of assisted reproductive technology (ART), and successful implantation depends on adequate endometrial receptivity. Different endometrial preparation protocols, including natural cycles and hormone replacement therapy (HRT) cycles, create distinct hormonal environments that may influence endometrial physiology. Among these protocols, HRT is the most widely used approach because it is applicable to a broad range of patients and offers greater flexibility in treatment scheduling.
Endometrial peristalsis, characterized by rhythmic contractions of the uterine junctional zone, is thought to play an important role in embryo transport and implantation. Previous studies have suggested that the frequency and direction of endometrial peristalsis are influenced by ovarian steroid hormones and may be associated with implantation and pregnancy outcomes. However, most available evidence has focused on natural menstrual cycles, while data regarding endometrial peristalsis during HRT-prepared FET cycles remain limited and inconsistent. The temporal changes in endometrial peristalsis throughout HRT endometrial preparation and their relationship with reproductive outcomes have not been fully elucidated.
This prospective observational study is designed to characterize endometrial peristalsis during HRT-prepared FET cycles using transvaginal ultrasonography and to evaluate the association between endometrial peristalsis and pregnancy outcomes. Endometrial peristalsis will be assessed at predefined time points during endometrial preparation, and pregnancy outcomes will be compared according to the observed peristaltic patterns. The results of this study are expected to improve understanding of endometrial physiology during HRT-prepared FET cycles and provide evidence on the clinical significance of endometrial peristalsis for reproductive outcomes.
- Conditions
- Infertility, Endometrial Peristalsis, Uterine Contraction, Endometrial Waves, Frozen Embryo Transfer (FET), Uterine Peristalsis
- Being tested
- Endometrial peristalsis and hormone measurements
- Keywords
- endometrial peristalsis, uterine contractions, endometrial waves, frozen embryo transfer, 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 of 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 progesterone initiation (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 progesterone initiation
- On the transfer day prior to the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Exogenous steroid protocol | The endometrium will be prepared with the use of oral estradiol valerate (Progynova®; Delpharm Lille SAS, France, or Valiera®, Laboratorios Recalcine) at a dose of 6 mg per day, starting on the second, third, or fourth day of the menstrual cycle. Endometrial thickness will be monitored from day 10 onward, and vaginal progesterone (Cyclogest, LD Collins, UK) at 800 mg per day and dydrogesterone (Duphaston, Abbott Biologicals B.V, US) at 20 mg per day will be started when the endometrial thickness reaches 8 mm or more. Embryo transfer was performed at 4 days for cleavage embryo transfer or at 6 days for blastocyst embryo transfer, after progesterone was started. All embryos were warmed on the day of transfer. 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.
The correlation between endometrial peristalsis at different time points and live birth rates
The correlation between endometrial peristalsis at different time points and live birth rates
Measured: Up to delivery
Secondary outcomes (27)
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 progesterone initiation (before progesterone exposure) • On the day of embryo transfer, immediately prior to the procedure
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 (before progesterone exposure) • On the day of embryo transfer, immediately prior to the procedure
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 (before progesterone exposure) • On the day of embryo transfer, immediately prior to the procedure
The association between endometrial peristalsis at different time points and pregnancy rates
The association between endometrial peristalsis at different time points and pregnancy rates
Measured: Up to delivery
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
Positive pregnancy test
Defined as serum human chorionic gonadotropin level ≥ 25 mIU/mL
Measured: 10-14 days after embryo transfer
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
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
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
Ectopic pregnancy
A pregnancy outside the uterine cavity, diagnosed by ultrasound, surgical visualization, or histopathology
Measured: Up to 12 weeks after embryo transfer
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
Multiple gestations
A pregnancy with more than one embryo or fetus
Measured: At delivery
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]
Mode of delivery
Vaginal delivery, C-section (elective, suspected fetal distress, non-progressive labor)
Measured: At delivery
Birth weight
Weight of the newborn measured right after delivery
Measured: At delivery
Gestational age at birth
Calculated by gestational age of all live births
Measured: At delivery
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
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
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
Measured: Up to delivery
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
Very low birth weight
Birth weight less than 1.500 g
Measured: Up to delivery
Low birth weight
Birth weight less than 2.500 g
Measured: Up to delivery
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
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]
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
NICU admission
The admission of the newborn to the NICU
Measured: Up to delivery
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.
- First posted30 Jun 2026
- Study start30 Jun 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- 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
- 442 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mỹ Đức Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lan N Vuong, MD, PhD, Principal investigator, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07675213
- Sponsor's protocol ID
- 17/26/DD-BVMD
- Acronym
- CONCO
- Status last verified
- Jul 2026
- First submitted
- 11 Jun 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Endometrial Peristalsis And Pregnancy Outcomes In Patients Undergoing Frozen Embryo Transfer With Hormone Replacement Therapy for Endometrial Preparation Protocol
- ClinicalTrials.gov ID
- NCT07675213
- Acronym / sponsor ID
- CONCO / 17/26/DD-BVMD
- Conditions
- Infertility, Endometrial Peristalsis, Uterine Contraction, Endometrial Waves, Frozen Embryo Transfer (FET), Uterine Peristalsis
- Keywords
- endometrial peristalsis, uterine contractions, endometrial waves, frozen embryo transfer, artificial cycles
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 442 participants (estimated)
- Lead sponsor
- Mỹ Đức HospitalUniversity, hospital or other
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 30 Jun 2026 (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.
Endometrial peristalsis may influence embryo implantation and pregnancy outcomes, but its role during hormone replacement therapy (HRT)-prepared frozen embryo transfer (FET) cycles remains unclear. This prospective observational study will assess endometrial peristalsis at predefined time points during HRT-prepared FET cycles using transvaginal ultrasonography and evaluate its association with pregnancy outcomes. The study aims to clarify the clinical significance of endometrial peristalsis in HRT-prepared FET cycles and to provide evidence supporting endometrial assessment in assisted reproductive technology.
Detailed description
Frozen embryo transfer (FET) has become an integral component of assisted reproductive technology (ART), and successful implantation depends on adequate endometrial receptivity. Different endometrial preparation protocols, including natural cycles and hormone replacement therapy (HRT) cycles, create distinct hormonal environments that may influence endometrial physiology. Among these protocols, HRT is the most widely used approach because it is applicable to a broad range of patients and offers greater flexibility in treatment scheduling.
Endometrial peristalsis, characterized by rhythmic contractions of the uterine junctional zone, is thought to play an important role in embryo transport and implantation. Previous studies have suggested that the frequency and direction of endometrial peristalsis are influenced by ovarian steroid hormones and may be associated with implantation and pregnancy outcomes. However, most available evidence has focused on natural menstrual cycles, while data regarding endometrial peristalsis during HRT-prepared FET cycles remain limited and inconsistent. The temporal changes in endometrial peristalsis throughout HRT endometrial preparation and their relationship with reproductive outcomes have not been fully elucidated.
This prospective observational study is designed to characterize endometrial peristalsis during HRT-prepared FET cycles using transvaginal ultrasonography and to evaluate the association between endometrial peristalsis and pregnancy outcomes. Endometrial peristalsis will be assessed at predefined time points during endometrial preparation, and pregnancy outcomes will be compared according to the observed peristaltic patterns. The results of this study are expected to improve understanding of endometrial physiology during HRT-prepared FET cycles and provide evidence on the clinical significance of endometrial peristalsis for reproductive outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exogenous steroid protocol | – | Other: Endometrial peristalsis and hormone measurementsThe endometrium will be prepared with the use of oral estradiol valerate (Progynova®; Delpharm Lille SAS, France, or Valiera®, Laboratorios Recalcine) at a dose of 6 mg per day, starting on the second, third, or fourth day of the menstrual cycle. Endometrial thickness will be monitored from day 10 onward, and vaginal progesterone (Cyclogest, LD Collins, UK) at 800 mg per day and dydrogesterone (Duphaston, Abbott Biologicals B.V, US) at 20 mg per day will be started when the endometrial thickness reaches 8 mm or more. Embryo transfer was performed at 4 days for cleavage embryo transfer or at 6 days for blastocyst embryo transfer, after progesterone was started. All embryos were warmed on the day of transfer. 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. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women undergoing hormone replacement therapy frozen embryo transfer during the study period
Key inclusion criteria (4 listed)
- Women aged 18 - 42 years old
- Scheduled for frozen embryo transfer cycles using hormone replacement therapy protocol
- Transferred no more than two cleavage embryos or one good-quality blastocyst or no more than two poor-quality blastocysts
- Provision of written informed consent to participate
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Endometrial peristalsis and hormone measurementsTime point for measurement of 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 progesterone initiation (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 progesterone initiation * On the transfer day prior to the procedure. | Other | Exogenous steroid protocol |
Primary outcome
The correlation between endometrial peristalsis at different time points and live birth rates
Time frame: Up to delivery
The correlation between endometrial peristalsis at different time points and live birth rates
27 secondary outcomes
The frequency of endometrial peristalsis 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 progesterone initiation (before progesterone exposure) • On the day of embryo transfer, immediately prior to the procedure
The correlation between endometrial peristalsis 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 progesterone initiation (before progesterone exposure) • On the day of embryo transfer, immediately prior to the procedure
Direction of peristalsis
Time frame: • On the second day to the fourth day of the menstrual cycle in the FET cycles • The day of progesterone initiation (before progesterone exposure) • On the day of embryo transfer, immediately prior to the procedure
The association between endometrial peristalsis at different time points and pregnancy rates
Time frame: Up to delivery
Live birth rates after the one embryo transfer
Time frame: At delivery
Positive pregnancy test
Time frame: 10-14 days after embryo transfer
Clinical pregnancy
Time frame: 4-6 weeks after embryo transfer
Ongoing pregnancy
Time frame: 12 weeks of gestation or beyond
Implantation rate
Time frame: At 4-6 weeks after embryo transfer
Ectopic pregnancy
Time frame: Up to 12 weeks after embryo transfer
Miscarriage
Time frame: Up to 22 weeks of gestation
Multiple gestations
Time frame: At delivery
Multiple birth
Time frame: At delivery]
Mode of delivery
Time frame: At delivery
Birth weight
Time frame: At delivery
Gestational age at birth
Time frame: At delivery
Preterm birth
Time frame: At delivery
Gestational diabetes mellitus
Time frame: At 24-28 weeks of gestation
Hypertensive disorders of pregnancy
Time frame: Up to delivery
Stillbirth
Time frame: Up to delivery
Very low birth weight
Time frame: Up to delivery
Low birth weight
Time frame: Up to delivery
High birth weight
Time frame: Up to delivery
Very high birth weight
Time frame: Up to delivery]
Major congenital abnormalities
Time frame: Up to delivery
NICU admission
Time frame: Up to delivery
Neonatal mortality
Time frame: Up to delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Lan N Vuong, MD, PhD principal investigator
University of Medicine and Pharmacy at Ho Chi Minh City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility and Endometrial Peristalsis, run by Mỹ Đức Hospital at 1 site 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 4 inclusion and 5 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 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Nhi NL Ho, MD (+84903497611, drnhiho@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The correlation between endometrial peristalsis at different time points and live birth rates (time frame: Up to delivery). 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 9 Jul 2026.