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NCT Number: NCT06644794

Progesterone-modified Natural Cycle for FET

Hormone replacement therapy (HRT) cycles, despite the ease of synchronizing embryo thawing and embryo transfer timing, increase the risk of pregnancies and obstetric complications compared to natural cycles (NC). By ensuring the presence of the corpus luteum while reducing the number of monitoring sessions, the progesterone modified natural cycle (P4mNC) offers more convenience for the patient than the normal NC. This study is designed to compare the effects of P4mNC and HRT cycles on FET outcomes.

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Key information

Conditions

Infertility, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Urogenital Diseases

Age range

21 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Jinan, Shandong, 250014, China

Location status: Recruiting

Location contact

Jing-Yan Song, MD

CONTACT

[email protected]

18765800113

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 21 to 44 years undergoing FBT
  • Body mass index (BMI) 18-35 kg/m2
  • Having regular ovulatory cycles

Exclusion criteria

  • Untreated uterine adhesions
  • Medical contraindications to estrogen and progesterone therapy
  • Illnesses contraindicating assisted reproductive technology or pregnancy
  • History of recurrent implantation failures (> 2 embryo transfer failures)

Treatment and study plan

Progesterone-modified natural cycle preparation for frozen embryo transfer

Drug

A novel endometrial preparation protocol that optimizes the natural cycle, whereby as long as the thickness of the endometrium is suitable for embryo transfer, vaginal progesterone can be used to transform the endometrium before ovulation and subsequently FET.

Hormone replacement therapy cycle preparation for frozen embryo transfer

Drug

A traditional endometrial preparation protocol is used for FET, which involves using fixed or flexible exogenous estradiol for artificial cycles. This protocol typically involves starting exogenous estradiol on day 3 or 4 of the cycle, continuing for 7-10 days, and then discontinuing. Upon determining that the endometrial thickness meets the standard, progesterone conversion of the endometrium can be performed.

Primary outcomes

  1. Live birth

    Time frame: Within 1 year after randomization

    A live birth is defined as the delivery of any surviving newborn at 28 weeks or more of gestation.

Secondary outcomes

  1. Biochemical pregnancy

    Time frame: Two weeks after embryo transfer

    Serum level of ß-hCG > 50 mIU/mL

  2. Clinical pregnancy

    Time frame: Five weeks after embryo transfer

    Fetal heartbeat observed by vaginal ultrasound

  3. Ongoing pregnancy

    Time frame: Ten weeks after embryo transfer

    The presence of a gestational sac and fetal heartbeat after 12 weeks of gestation

  4. Miscarriage

    Time frame: Within 28 weeks of pregnancy

    A condition in which the embryo or fetus does not survive and is not spontaneously absorbed or expelled from the uterus

Study contacts

Contact information is provided by the study sponsor or research team.

Xian-Ling Cao, MD

CONTACT

[email protected]

0531-68901236

Sponsors and collaborators

Lead sponsor

Shandong University of Traditional Chinese Medicine

Other

Registry information

Official study title

Comparison of Progesterone-modified Natural Cycle and Hormone Replacement Therapy Cycle for Endometrial Preparation in Single Frozen Blastocyst Transfer

Acronym: COMPROSET

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Oct 16, 2024
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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