Prospective trial for evaluation of efficacy of conservative debulking surgery in infertile women with uterine adenomyosis
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 50
研究概览
简要总结
The mean age and the duration of infertility were 35.60 ± 3.33 years and 55.48 ± 48.24 months, respectively. The mean weight of excised specimens of adenomyosis was 94.15 ± 56.63 g. Relief of dysmenorrhea was observed clearly in all patients at 6 months postoperatively (numeric rating scale; 7.28 ± 2.30 vs. 1.56 ± 1.30, P < 0.001). The amount of menstrual blood significantly decreased (140.44 ± 91.68 vs. 66.33 ± 65.85 mL, P < 0.05). The cancer antigen 125 (CA 125) level also significantly decreased at 6 months postoperatively (187.75 ± 221.13 vs. 20.78 ± 19.28 IU/mL, P < 0.05). Postoperative complications occurred in four patients (uterine shrinkage, premature ovarian insufficiency, ureter fistula, and subfascial hematoma). Of 33 patients who attempted pregnancy, 18 (54.5%) conceived by natural pregnancy, IVF-ET, or thawing ET postoperatively; miscarriage occurred in 8 patients while 10 (30.3%) patients had viable pregnancies. The number of live births was 13; two patients had twin pregnancies, and one patient delivered twice. There were two preterm deliveries among 11 viable pregnancies. There was no uterine rupture or caesarean hysterectomy.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 49(Year)（—）
- 性别
- Female
入选标准
- •1. Patients diagnosed with adenomyosis via pelvic ultrasonography and magnetic resonance imaging (MRI) who had excessive menstrual flow and severe dysmenorrhea that disrupted daily life
- •2. Patients who had been diagnosed with primary or secondary infertility for more than a year, and their infertility was determined to be because of adenomyosis based on clinical assessments by an infertility exper
- •3. Patients who did not have any other medical conditions, excluding iron deficiency anaemia
- •4. Patients who failed to conceive after treatment with drugs, such as gonadotropin-releasing hormone agonist (GnRHa)
- •5. Infertile patients who had adenomyosis and other infertility factors, such as ovulation disorder and blocked fallopian tube,yet their implantation failure was determined to be because of adenomyosis after more than two failed attempts to conceive through IVF-ET and/or ovulation induction
排除标准
- •1. Patients with gynecologic malignancies such as cervical cancer or ovarian cancer
- •2. Patients with severe medical disease
- •3. Patients with active bacterial infection which needs parenteral antibiotics treatment
- •4. Patients who received pelvic irradiation due to malignancies
- •5. Patients with other severe medical disease
- •6. Patients with psychologic disorder
- •7. Patients who is impossible to participate in clinical trial by the law