Endometrial Peristalsis and Pregnancy Outcomes in Hormone Replacement Therapy (HRT) - Frozen Embryo Transfer (FET) Cycles

Sponsor
Mỹ Đức Hospital
Study ID
NCT07675213
Status
Recruiting
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Conditions

  • Endometrial Peristalsis
  • Endometrial Waves
  • Frozen Embryo Transfer (FET)
  • Hormone Replacement Therapy (HRT)
  • Infertility
  • Uterine Contraction
  • Uterine Peristalsis

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 42 Years
Healthy Volunteers
Not accepted

Interventions

  • Endometrial peristalsis and hormone measurements — OTHER
    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 Details

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.

Key Dates

First listed
Jun 30, 2026
Start date
Jun 30, 2026
Status verified
Jul 2026
Primary completion
Jun 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
442 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

The correlation between endometrial peristalsis at different time points and live birth rates [ Time Frame: Up to delivery ]

Central Contacts

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