search
Back to results

Prolonged Progesterone to Prevent Preterm Birth From IVF - ET

Primary Purpose

Preterm Birth

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Progesterone Sustained-release vaginal gel
Sponsored by
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Birth

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: 1. 20-40 years old 2. met the conditions of assisted reproductive technology and underwent IVF fresh embryo transplantation 3. Singleton pregnancy 4. Patients volunteered and signed informed consent prior to the trial. Exclusion Criteria: 1. >40 years old 2. History of miscarriage or cervical insufficiency in the second trimester 3. Abnormal ovarian function or surgical history: decline in ovarian reserve, premature ovarian failure, Turner's syndrome, ovarian cyst excision, PCOS perforation/coning, chocolate cyst surgery, ovarian cone resection 4. Uterine deformities: including single horn uterus, double horn uterus, residual horn uterus, saddle uterus, infantile uterus, double uterus, mediastinal uterus 5. Diseases affecting uterine shape: uterine adhesions, uterine submucosal myomas or polyps, adenomyosis, chronic inflammation of the endometrium 6. Abnormalities in cervical morphology or function. 7. History of total cervicectomy, conical excision, and cervical insufficiency 8. Vaginal inflammation: refractory candida vaginitis, bacterial vaginosis, persistent mycoplasma-positive vaginosis, persistent chlamydia-positive vaginosis 9. B ultrasonography indicates twin or multiple pregnancies 10. Patients with severe medical and surgical diseases 11. Participants who had participated in other clinical trials during the 90 days or had received any investigational clinical drug during the 30 days prior to the trial 12. Patients with no long-term follow-up or poor compliance 13. The investigator believes that there are any factors that may affect participants' participation in the study or the evaluation of the results

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    The Trial group

    The control group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Incidence of preterm birth
    the symptom or diagnosis of preterm birth

    Secondary Outcome Measures

    Full Information

    First Posted
    March 15, 2023
    Last Updated
    March 15, 2023
    Sponsor
    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05787509
    Brief Title
    Prolonged Progesterone to Prevent Preterm Birth From IVF - ET
    Official Title
    The Exploration of Prolonged Treatment With Vaginal Progesterone to Prevent Preterm Birth From IVF Fresh Embryo Transplantation Cycle: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2023 (Anticipated)
    Primary Completion Date
    February 28, 2025 (Anticipated)
    Study Completion Date
    February 28, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    To investigate the incidence of preterm birth in IVF fresh embryo transplantation cycle patients after prolonged vaginal progesterone treatment
    Detailed Description
    Participant: 20-40 years old, IVF fresh embryo transplantation, singleton pregnancy, blood/urine HCG (+) 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Preterm Birth

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    The Trial group
    Arm Type
    Experimental
    Arm Description
    we will prolong the duration of vaginal progesterone treatment until 24 weeks of gestation.
    Arm Title
    The control group
    Arm Type
    Experimental
    Arm Description
    we will use vaginal progesterone treatment until 12 weeks of gestation.
    Intervention Type
    Drug
    Intervention Name(s)
    Progesterone Sustained-release vaginal gel
    Other Intervention Name(s)
    Vaginal progesterone
    Intervention Description
    the treatment time of vaginal progesterone
    Primary Outcome Measure Information:
    Title
    Incidence of preterm birth
    Description
    the symptom or diagnosis of preterm birth
    Time Frame
    37 weeks of gestation

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 1. 20-40 years old 2. met the conditions of assisted reproductive technology and underwent IVF fresh embryo transplantation 3. Singleton pregnancy 4. Patients volunteered and signed informed consent prior to the trial. Exclusion Criteria: 1. >40 years old 2. History of miscarriage or cervical insufficiency in the second trimester 3. Abnormal ovarian function or surgical history: decline in ovarian reserve, premature ovarian failure, Turner's syndrome, ovarian cyst excision, PCOS perforation/coning, chocolate cyst surgery, ovarian cone resection 4. Uterine deformities: including single horn uterus, double horn uterus, residual horn uterus, saddle uterus, infantile uterus, double uterus, mediastinal uterus 5. Diseases affecting uterine shape: uterine adhesions, uterine submucosal myomas or polyps, adenomyosis, chronic inflammation of the endometrium 6. Abnormalities in cervical morphology or function. 7. History of total cervicectomy, conical excision, and cervical insufficiency 8. Vaginal inflammation: refractory candida vaginitis, bacterial vaginosis, persistent mycoplasma-positive vaginosis, persistent chlamydia-positive vaginosis 9. B ultrasonography indicates twin or multiple pregnancies 10. Patients with severe medical and surgical diseases 11. Participants who had participated in other clinical trials during the 90 days or had received any investigational clinical drug during the 30 days prior to the trial 12. Patients with no long-term follow-up or poor compliance 13. The investigator believes that there are any factors that may affect participants' participation in the study or the evaluation of the results

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Prolonged Progesterone to Prevent Preterm Birth From IVF - ET

    We'll reach out to this number within 24 hrs