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

NCT07675213 | Recruiting

• 1 other identifier: 17/26/DD-BVMD
• Study Type: observational
• Target: 442
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

endometrial peristalsis; uterine contractions; endometrial waves; frozen embryo transfer; artificial cycles

Outcome Measures

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

  Up to delivery

Secondary Outcomes (27)

• The frequency of endometrial peristalsis at different 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

• The correlation between endometrial peristalsis at different 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

• Direction of peristalsis

  • 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

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

  Up to delivery

• Live birth rates after the one embryo transfer

  At delivery

Study Arms (1)

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.

Other: Endometrial peristalsis and hormone measurements

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.

Exogenous steroid protocol

Eligibility Criteria

• Age: 18 Years - 42 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mỹ Đức Hospital: lead

Study Sites (1)

IVFMD - My Duc Hospital

Ho Chi Minh City, 70000, Vietnam

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Lan N Vuong, MD, PhD

  University of Medicine and Pharmacy at Ho Chi Minh City

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nhi NL Ho, MD

CONTACT

+84903497611; drnhiho@gmail.com

Vu NA Ho, MD, PhD

CONTACT

+84935843336; bsvu.hna@myduchospital.vn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 30, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)