Preterm BirthPhase 4NCT05787509
Prolonged Progesterone to Prevent Preterm Birth From IVF - ET
A Phase 4 study testing Progesterone Sustained-release vaginal gel in people with Preterm Birth, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
To investigate the incidence of preterm birth in IVF fresh embryo transplantation cycle patients after prolonged vaginal progesterone treatment Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Progesterone Sustained-release vaginal gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 30 Apr 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital
Guangzhou
Hui Chen, 86-020-81332233, zheling76@163.com
About this study
Official title: The Exploration of Prolonged Treatment With Vaginal Progesterone to Prevent Preterm Birth From IVF Fresh Embryo Transplantation Cycle: a Randomized Controlled Trial
To investigate the incidence of preterm birth in IVF fresh embryo transplantation cycle patients after prolonged vaginal progesterone treatment
Read the 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.
- Conditions
- Preterm Birth
- Being tested
- Progesterone Sustained-release vaginal gel
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progesterone Sustained-release vaginal gelDrug
Also called Vaginal progesterone
the treatment time of vaginal progesterone
| Study group | Role | What they receive |
|---|---|---|
| The Trial group | Experimental | we will prolong the duration of vaginal progesterone treatment until 24 weeks of gestation. Receives: Drug: Progesterone Sustained-release vaginal gel |
| The control group | Experimental | we will use vaginal progesterone treatment until 12 weeks of gestation. Receives: Drug: Progesterone Sustained-release vaginal gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of preterm birth
the symptom or diagnosis of preterm birth
Measured: 37 weeks of gestation
Secondary outcomes (2)
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.
Measured: 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.
Measured: Cervical length is measured via ultrasound at 12, 16, 20, and 24 weeks of gestation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start1 Apr 2023
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, chenhui79, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05787509
- Sponsor's protocol ID
- SYSKY-2022-389-01
- Status last verified
- Jun 2026
- First submitted
- 15 Mar 2023
- Last updated
- 11 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Exploration of Prolonged Treatment With Vaginal Progesterone to Prevent Preterm Birth From IVF Fresh Embryo Transplantation Cycle: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05787509
- Acronym / sponsor ID
- SYSKY-2022-389-01
- Conditions
- Preterm Birth
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 28 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the incidence of preterm birth in IVF fresh embryo transplantation cycle patients after prolonged vaginal progesterone 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Trial group | Experimental | Drug: Progesterone Sustained-release vaginal gelwe will prolong the duration of vaginal progesterone treatment until 24 weeks of gestation. |
| The control group | Experimental | Drug: Progesterone Sustained-release vaginal gelwe will use vaginal progesterone treatment until 12 weeks of gestation. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progesterone Sustained-release vaginal gelAlso: Vaginal progesteronethe treatment time of vaginal progesterone | Drug | The Trial group, The control group |
Primary outcome
Incidence of preterm birth
Time frame: 37 weeks of gestation
the symptom or diagnosis of preterm birth
2 secondary outcomes
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.
cervical length
Time frame: Cervical length is measured via ultrasound at 12, 16, 20, and 24 weeks of gestation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Progesterone Sustained-release vaginal gel in people with Preterm Birth, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of preterm birth (time frame: 37 weeks of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.