NCT07358468 Impact Of FET Preparation Protocol On Endometrial Peristalsis: A Prospective Cohort Study
| NCT ID | NCT07358468 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mỹ Đức Hospital |
| Condition | Infertility |
| Study Type | OBSERVATIONAL |
| Enrollment | 356 participants |
| Start Date | 2026-02-22 |
| Primary Completion | 2026-12-01 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 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.
Eligibility Criteria
Inclusion Criteria: * 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 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. * PCOS patients