Progesterone-modified Natural Cycle for FET

Phase 3Not Yet RecruitingNCT06644794

Shandong University of Traditional Chinese Medicine336 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

336

Conditions

Infertility, Female

Interventions

Progesterone-modified natural cycle preparation for frozen embryo transferDRUG

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 transferDRUG

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.

Eligibility

Sex: FEMALEMin age: 21 YearsMax age: 44 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Live birth

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

Time frame: Within 1 year after randomization

Secondary Outcomes

Biochemical pregnancy

Serum level of ß-hCG \> 50 mIU/mL

Time frame: Two weeks after embryo transfer

Clinical pregnancy

Fetal heartbeat observed by vaginal ultrasound

Time frame: Five weeks after embryo transfer

Ongoing pregnancy

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

Time frame: Ten weeks after embryo transfer

Miscarriage

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

Time frame: Within 28 weeks of pregnancy

Central Contacts

Xian-Ling Cao, MD

CONTACT

0531-68901236 caoxianlingling@163.com

Data from ClinicalTrials.gov

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