To investigate the incidence of preterm birth in IVF fresh embryo transplantation cycle patients after prolonged vaginal progesterone treatment
Inclusion criteria were: age 20-40 years; indication for assisted reproductive technology (ART) with fresh embryo transfer via in vitro fertilization (IVF); singleton pregnancy; and willingness to participate and provide written informed consent. Exclusion criteria were: age \>40 years; history of second-trimester miscarriage or cervical insufficiency; ovarian dysfunction or prior ovarian surgery; uterine malformation; conditions associated with abnormal uterine cavity morphology; abnormal cervical morphology or function, or history of cervical surgery; refractory vaginitis; multiple pregnancy; severe medical or surgical comorbidities; participation in another clinical trial within 90 days before randomization, or use of an investigational drug within 30 days; inability or poor compliance for long-term follow-up; and any other condition that, in the investigator's judgment, could interfere with trial implementation or outcome evaluation. Control group: The administration of vaginal progesterone (90mg/d) began from positive HCG in blood/urine until 12 weeks of gestation. Regular delivery examinations were conducted, and cervical length was detected by B-ultrasound at 12, 16, 20 and 24 weeks of gestation respectively, while fetal growth and development were monitored. Follow-up was continued until the end of delivery. Trial group: The administration of vaginal progesterone (90mg/d) began from positive HCG in blood/urine until 24 weeks of gestation. Regular delivery examinations were conducted, and cervical length was detected by B-ultrasound at 12, 16, 20 and 24 weeks of gestation respectively, while fetal growth and development were monitored. Follow-up was continued until the end of delivery. Observation index: The gestational age of delivery, symptoms of preterm birth and gestational age, gestational age at preterm birth or abortion, fetal growth and development, neonatal outcomes, and drug-related adverse reactions were recorded for each participant.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
100
the treatment time of vaginal progesterone
Sun Yat-sen Memorial Hospital
Guangzhou, China
RECRUITINGIncidence of preterm birth
the symptom or diagnosis of preterm birth
Time frame: 37 weeks of gestation
live birth rate
Live birth is defined as the delivery of a neonate with heartbeat and breath at or beyond 28 gestational weeks. Live birth rate is calculated as the number of live births divided by the number of clinical pregnancies.
Time frame: The time frame is from the date of fresh embryo transfer until delivery, assessed up to 42 weeks of gestation plus 4 weeks post-delivery.
cervical length
The measurement is performed along the endocervical canal from the internal os to the external os.
Time frame: Cervical length is measured via ultrasound at 12, 16, 20, and 24 weeks of gestation.
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