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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 42
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Viet Nam
IVFMD Phu Nhuan - My Duc Phu Nhuan Hospital
NOT_YET_RECRUITING
Ho Chi Minh City
My Duc Phu Nhuan Hospital
RECRUITING
Ho Chi Minh City
Contact Information
Primary
Xuyen Thi Ha Le, MD
bsxuyen.lth@myduchospital.vn
+84945260494
Backup
Tuong M Ho, MD
tuongho.ivfmd@gmail.com
+84903633377
Time Frame
Start Date: 2026-02-22
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 384
Treatments
Modified natural cycle
On 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.
Sponsors
Collaborators: My Duc Phu Nhuan Hospital HCMC, Vietnam
Leads: Mỹ Đức Hospital

This content was sourced from clinicaltrials.gov