Infertility Clinical Trials

Find Infertility Clinical Trials Near You

Effects Of Endometrial Preparation Protocols On Peristalsis And Pregnancy Rates 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: 356
Treatments
Exogenous steroid protocol
The endometrium was 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 was monitored from day 10 onward, and vaginal progesterone (Cyclogest, LD Collins, UK) at a dose of 800 mg per day and dydrogesterone (Duphaston, Abbott Biologicals B.V, US) at a dose of 20 mg per day were started when the endometrial thickness reached 8 mm or more. Embryo transfer was performed at 4 days for cleavage embryos transfer or 6 days for blastocyst embryo transfer after starting progesterone. 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.
Natural protocol (True natural cycle or modified natural cycle)
Daily ultrasound and serum estradiol and LH level evaluation will be performed when the mean diameter of the dominant follicle of ≥14 mm. On natural cycle, LH surge initiation is defined as a concentration of 180% above the latest serum value available in that patient with a continued rise thereafter to a level of 20 IU/l or more detected by the ECLIA method (Roche Cobas® E 801, Roche Diagnostics, Germany). On modified natural cycle, when the mean diameter of the dominant follicle is ≥16 mm, human chorionic gonadotropin (hCG, Ovitrelle® 250 µg; Merck, USA) 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 the LH surge/ hCG injection. Embryo transfer will be scheduled by the time of the initiation of LH 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
Sponsors
Collaborators: My Duc Phu Nhuan Hospital HCMC, Vietnam
Leads: Mỹ Đức Hospital

This content was sourced from clinicaltrials.gov