NCT05787509

Brief Summary

To investigate the incidence of preterm birth in IVF fresh embryo transplantation cycle patients after prolonged vaginal progesterone treatment

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
33mo left

Started Apr 2023

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress55%
Apr 2023Apr 2029

First Submitted

Initial submission to the registry

March 15, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 28, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2029

Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

6.1 years

First QC Date

March 15, 2023

Last Update Submit

June 8, 2026

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (1)

  • Incidence of preterm birth

    the symptom or diagnosis of preterm birth

    37 weeks of gestation

Secondary Outcomes (2)

  • live birth rate

    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

    Cervical length is measured via ultrasound at 12, 16, 20, and 24 weeks of gestation.

Study Arms (2)

The Trial group

EXPERIMENTAL

we will prolong the duration of vaginal progesterone treatment until 24 weeks of gestation.

Drug: Progesterone Sustained-release vaginal gel

The control group

EXPERIMENTAL

we will use vaginal progesterone treatment until 12 weeks of gestation.

Drug: Progesterone Sustained-release vaginal gel

Interventions

Progesterone Sustained-release vaginal gelDRUG

the treatment time of vaginal progesterone

Also known as: Vaginal progesterone
The Trial groupThe control group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen Memorial Hospital

Guangzhou, China

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 15, 2023

First Posted

March 28, 2023

Study Start

April 1, 2023

Primary Completion (Estimated)

April 30, 2029

Study Completion (Estimated)

April 30, 2029

Last Updated

June 11, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)