Progesterone-modified Natural Cycle for FET
- Conditions
- Infertility, Female
- Interventions
- Drug: Progesterone-modified natural cycle preparation for frozen embryo transferDrug: Hormone replacement therapy cycle preparation for frozen embryo transfer
- Registration Number
- NCT06644794
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 336
- Patients aged 21 to 44 years undergoing FBT
- Body mass index (BMI) 18-35 kg/m2
- Having regular ovulatory cycles
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description P4mNC group Progesterone-modified natural cycle preparation for frozen embryo transfer On days 8-12 of the menstrual cycle (MC), depending on the length of the patient's MC, transvaginal ultrasound is used to monitor follicular development and endometrial growth. Vaginal micronized progesterone (Utrogestan, Besins, Belgium) is started at 200 mg in the afternoon and 200 mg in the evening when the dominant follicle reached ≥16 mm and the endometrial thickness is at least 7 mm. A blastocyst is transferred on day 5 after the addition of progesterone. On day 14 after blastocyst transfer, serum β-hCG levels are measured. Upon positive serum pregnancy testing, progesterone support will continue until 8-10 weeks of gestation. However, afternoon progesterone use is eliminated for 30 days after embryo transfer. HRT group Hormone replacement therapy cycle preparation for frozen embryo transfer Endometrial preparation will begin on the second day of the menstrual cycle with oral estradiol (E2) valerate at a dose of 2 mg twice daily. When the patient's endometrial thickness is ≥7 mm, vaginal progesterone administration will be initiated at a dose of 200 mg 3 times daily. On day 5 of the progesterone administration, blastocysts are thawed and transferred. For patients with endometrial thickness \<7 mm, patients continued oral E2 until the endometrium is ≥7 mm. On day 14 after blastocyst transfer, serum β-hCG levels are measured. Upon positive serum pregnancy testing, E2 and progesterone supplementation is continued for 8-10 weeks of gestation.
- Primary Outcome Measures
Name Time Method Live birth 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 Outcome Measures
Name Time Method Biochemical pregnancy Two weeks after embryo transfer Serum level of ß-hCG \> 50 mIU/mL
Clinical pregnancy Five weeks after embryo transfer Fetal heartbeat observed by vaginal ultrasound
Ongoing pregnancy Ten weeks after embryo transfer The presence of a gestational sac and fetal heartbeat after 12 weeks of gestation
Miscarriage 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