Prolonged Progesterone to Prevent Preterm Birth From IVF - ET

NCT ID: NCT05787509

Last Updated: 2023-03-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2025-02-28

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.

Conditions

Preterm Birth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

The Trial group

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

Group Type: EXPERIMENTAL

Progesterone Sustained-release vaginal gel

Intervention Type: DRUG

the treatment time of vaginal progesterone

The control group

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

Group Type: EXPERIMENTAL

Progesterone Sustained-release vaginal gel

Intervention Type: DRUG

the treatment time of vaginal progesterone

Interventions

Progesterone Sustained-release vaginal gel

the treatment time of vaginal progesterone

Intervention Type: DRUG

Other Intervention Names

Vaginal progesterone

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

SYSKY-2022-389-01

Identifier Type: -

Identifier Source: org_study_id