Prolonged Progesterone to Prevent Preterm Birth From IVF - ET
The Exploration of Prolonged Treatment With Vaginal Progesterone to Prevent Preterm Birth From IVF Fresh Embryo Transplantation Cycle: a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Guangzhou, China
- Recruiting
- Sun Yat-sen Memorial Hospital
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Contact:
- Hui Chen
- Phone Number: 86-020-81332233
- Email: zheling76@163.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion criteria are: age 20-40 years; meeting the indications for assisted reproductive technology (ART) and undergoing fresh embryo transfer with in vitro fertilization (IVF); singleton pregnancy; and willingness to participate and provide written informed consent.
Exclusion criteria are: age >40 years; history of second-trimester miscarriage or cervical insufficiency; ovarian dysfunction or relevant surgical history; uterine malformation; diseases associated with abnormal uterine cavity morphology; abnormal cervical morphology or function, or history of cervical surgery; refractory vaginitis; multiple pregnancy; concomitant severe medical or surgical diseases; participation in another clinical trial within 90 days prior to randomization, or use of an investigational drug within 30 days; inability to complete long-term follow-up or poor compliance; and any other condition that, in the investigator's judgment, may affect trial implementation or outcome evaluation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: The Trial group
we will prolong the duration of vaginal progesterone treatment until 24 weeks of gestation.
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the treatment time of vaginal progesterone
Other Names:
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Experimental: The control group
we will use vaginal progesterone treatment until 12 weeks of gestation.
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the treatment time of vaginal progesterone
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Incidence of preterm birth
Time Frame: 37 weeks of gestation
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the symptom or diagnosis of preterm birth
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37 weeks of gestation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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live birth rate
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.
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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. |
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.
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cervical length
Time Frame: Cervical length is measured via ultrasound at 12, 16, 20, and 24 weeks of gestation.
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The measurement is performed along the endocervical canal from the internal os to the external os.
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Cervical length is measured via ultrasound at 12, 16, 20, and 24 weeks of gestation.
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SYSKY-2022-389-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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