Prolonged vaginal progesterone to help prevent preterm birth after IVF with fresh embryos
Official title: The Exploration of Prolonged Treatment With Vaginal Progesterone to Prevent Preterm Birth From IVF Fresh Embryo Transplantation Cycle: a Randomized Controlled Trial
Run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · NCT05787509 · Data updated 2026-11-12
In people undergoing IVF with a fresh embryo, this study tests whether extending vaginal progesterone treatment reduces the risk of preterm birth.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 20 Years to 40 Years |
| Sex | Women only |
| Enrollment | 100 (estimated) |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Locations | 1 site (Guangzhou) |
| Status | Recruiting |
| Started | April 1, 2023 |
| Main results expected | April 30, 2029 |
| Study ends | April 30, 2029 |
| Registry record updated | June 11, 2026 |
| Trial ID | NCT05787509 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 20–40 with a singleton IVF pregnancy after fresh embryo transfer, willing to comply with long-term follow-up.
✕Probably not a fit
Patients who do not have a shortened cervical length or other risk factors for preterm birth may not experience additional benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study examines whether prolonging vaginal progesterone from the time of a positive pregnancy test through 24 weeks of gestation lowers preterm birth risk in singleton pregnancies after fresh IVF embryo transfer. Participants are adults aged 20–40 with an ART indication and singleton pregnancies, randomized to receive progesterone until 24 weeks vs. until 12 weeks with ongoing monitoring. Outcomes include preterm birth incidence and cervical length assessments via ultrasound at specified gestational ages. Safety and adherence are monitored, with follow-up through delivery.
Why it matters
Potential benefit: If successful, prolonging progesterone could reduce preterm births and improve neonatal outcomes for IVF pregnancies.
How similar studies have gone: Previous studies in similar settings have shown some promise with vaginal progesterone for preterm birth prevention, but results vary by protocol and population.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Sun Yat-sen Memorial Hospital
Guangzhou, China Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.