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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-42
SponsorMỹ Đức Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Women undergoing hormone replacement therapy frozen embryo transfer during the study period

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Endometrial peristalsis and hormone measurements

    Other intervention

    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.

Treatment groups

442 Participants
are divided into 1 treatment group
Group A: Exogenous steroid protocol1 intervention

Trial outcomes

Primary outcomes

1

The correlation between endometrial peristalsis at different time points and live birth rates

The correlation between endometrial peristalsis at different time points and live birth rates

Time frame
Up to delivery

Secondary outcomes

1

The frequency of endometrial peristalsis at different time points

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
2

The correlation between endometrial peristalsis at different time points

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
3

Direction of peristalsis

Direction of peristalsis is categorized as cervix-to-fundus, fundus-to-cervix, indeterminate, or absent (no contractions observed)

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
4

The association between endometrial peristalsis at different time points and pregnancy rates

The association between endometrial peristalsis at different time points and pregnancy rates

Time frame
Up to delivery

Other outcomes

Sponsors and contacts

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