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临床试验/CTRI/2025/09/095148
CTRI/2025/09/095148尚未招募4 期

Role of intrauterine antibiotic infusion combined with oral antibiotic administration in improving pregnancy outcome in women with chronic endometritis diagnosed by CD138 test seeking care for failed IVF.

Datta Meghe Institute of Higher Education and Research1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年11月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Biochemical Pregnancy Rate (Beta HCG) and Clinical Pregnancy Rate (Gestational Sac and fetal heart sound on USG)

研究概览

简要总结

This study is a prospective, randomised controlled trial conducted at the Wardha Test Tube Baby Centre, AVBRH, DMIHER, India, evaluating the efficacy of oral antibiotic administration (OAA) alone versus combined intrauterine antibiotic infusion plus oral antibiotic administration (OAA+IAI) in women with CD138-confirmed chronic endometritis (CE) and at least one prior failed in-vitro fertilisation (IVF) cycle. The hypothesis is that combined intrauterine and oral antibiotic therapy will improve pregnancy outcomes compared to oral antibiotics alone. Forty women (20 per arm) were allocated to receive either OAA (doxycycline + metronidazole) for 14 days or OAA plus intrauterine ciprofloxacin infusions every 3 days for 30 days. The primary outcomes were biochemical and clinical pregnancy rates; secondary outcomes included implantation rate, miscarriage rate, and treatment tolerability. The study found no statistically significant differences in pregnancy outcomes between groups, suggesting that oral antibiotic therapy alone may be sufficient for CE management in IVF failure cases, particularly in resource-limited settings.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
19.00 Year(s) 至 39.00 Year(s)(—)
性别
Female

入选标准

  • Positive diagnosis of Chronic endometriosis Previous IVF Failure Recurrent Pregnancy Loss (RPL) or Recurrent implantation Failure (RIF) No previous live birth FSH and LH levels evaluated on day 2 of menstrual cycle less than 12 IU/ml AMH levels greater than 1.1 ng/ml Progestrone levels evaluated on day 21 of menstrual cycle greater than 2 and less than 25 ng/ml BMI greater than 18.5 and less than 29.9.

排除标准

  • Diagnosed endometriosis or other related Pelvic Inflammatory Disorder (PID) Current or previous cancer diagnosis.
  • Auto-immune, genetic or reproductive disorders.
  • Reproductive history of pregnancy loss due to genetic abnormalities.
  • Male factor infertility diagnosis.

结局指标

主要结局

Biochemical Pregnancy Rate (Beta HCG) and Clinical Pregnancy Rate (Gestational Sac and fetal heart sound on USG)

时间窗: 2-3 weeks after embryo transfer and 6-8 weeks post embryo transfer

次要结局

未报告次要终点

研究者

发起方
Datta Meghe Institute of Higher Education and Research
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Apoorva Dave

Department of Obstetrics and Gynecology, Datta Meghe Institute of Higher Education and Research

研究点 (1)

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