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A novel method of surgery for the infertile women with adenomyosis

Not Applicable
Completed
Conditions
Diseases of The genitoruinary system
Registration Number
KCT0004135
Lead Sponsor
Dongguk University Ilsan Hospital
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Female
Target Recruitment
50
Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Pregnancy and its outcome
Secondary Outcome Measures
NameTimeMethod
Dysmenorrhea and menorrhagia
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