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NCT Number: NCT05787509

Prolonged Progesterone to Prevent Preterm Birth From IVF - ET

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

Recruiting

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Progesterone Sustained-release vaginal gel

Drug

the treatment time of vaginal progesterone

Other names: Vaginal progesterone

Primary outcomes

  1. Incidence of preterm birth

    Time frame: 37 weeks of gestation

    the symptom or diagnosis of preterm birth

Secondary outcomes

  1. 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.

    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.

  2. cervical length

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

    The measurement is performed along the endocervical canal from the internal os to the external os.

Sponsors and collaborators

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Other

Registry information

Official study title

The Exploration of Prolonged Treatment With Vaginal Progesterone to Prevent Preterm Birth From IVF Fresh Embryo Transplantation Cycle: a Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Mar 28, 2023
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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