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Prolonged Progesterone to Prevent Preterm Birth From IVF - ET

Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05787509
Collaborator
(none)
100
Enrollment
2
Arms
23
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Progesterone Sustained-release vaginal gel
 Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Exploration of Prolonged Treatment With Vaginal Progesterone to Prevent Preterm Birth From IVF Fresh Embryo Transplantation Cycle: a Randomized Controlled Trial
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Feb 28, 2025
Anticipated Study Completion Date :
Feb 28, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: The Trial group

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

Drug: Progesterone Sustained-release vaginal gel
the treatment time of vaginal progesterone
Other Names:
  • Vaginal progesterone

    		•
    Experimental: The control group

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

    Drug: Progesterone Sustained-release vaginal gel
    the treatment time of vaginal progesterone
    Other Names:
  • Vaginal progesterone

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of preterm birth [37 weeks of gestation]

      the symptom or diagnosis of preterm birth

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
    ClinicalTrials.gov Identifier:
    NCT05787509
    Other Study ID Numbers:
    • SYSKY-2022-389-01
    First Posted:
    Mar 28, 2023
    Last Update Posted:
    Mar 28, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Premature Birth
    Progesterone

    Study Results

    No Results Posted as of Mar 28, 2023