Endometrial Peristalsis and Pregnancy Outcomes in Hormone Replacement Therapy (HRT) - Frozen Embryo Transfer (FET) Cycles
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Endometrial peristalsis and hormone measurements.
- Who it may be relevant to
- Registry conditions: Infertility, Endometrial Peristalsis, Uterine Contraction, Endometrial Waves. Basic parameters: 18 years — 42 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Vietnam
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Correlation Between Endometrial Peristalsis And Pregnancy Outcomes In Patients Undergoing Frozen Embryo Transfer With Hormone Replacement Therapy for Endometrial Preparation Protocol
Overview
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.
Interventions
- Other Endometrial peristalsis and hormone measurements
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 electro
Primary outcome measures
- The correlation between endometrial peristalsis at different time points and live birth rates [Time frame: Up to delivery]
Secondary outcome measures (12)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Vietnam · 1 center
- IVFMD - My Duc Hospital — Ho Chi Minh City
Identifiers
NCT: NCT07675213 · 17/26/DD-BVMD