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临床试验/NCT03334955
NCT03334955已完成不适用

Effect of Laparoscopic Ovarian Drilling on Subendometrial Blood Flow in Women With Polycystic Ovary Syndrome

Zagazig University0 个研究点目标入组 200 人开始时间: 2016年7月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
200
主要终点
Subendometrial blood flow

研究概览

简要总结

Serum level of total testosterone was measured in the early follicular phase (days 2-4 of spontaneous cycle in oligomenorrhic patients). To start the study in amenorrhic patients (after exclusion of pregnancy) they received progesterone (oral Norethisterone Acetate 10 mg daily for 5 days) to induce withdrawal bleeding and total testosterone was measured in days 2-4 of this withdrawal bleeding.

Color Doppler ultrasound scanning will be performed to assess the subendometrial blood flow. The subendometrial region was observed and analyzed in each woman using color and power Doppler flow ultrasonography. By means of color and power Doppler flow imaging, color signals was searched for in the subendometrial region and areas of maximum color intensity, representing the greatest Doppler frequency shifts, was visualized, then selected for pulsed Doppler examination. Pulsatility index (PI) and resistance index (RI) were calculated in each selected Doppler wave.

Laparoscopic ovarian drilling was performed under general anesthesia with good muscle relaxation and endotracheal intubation using the three-punctures technique (one puncture 10mm at the umbilicus and the other two punctures 5mm at both iliac fossa) in the early follicular phase (after stoppage of menstrual or withdrawal bleeding).

A specially designed monopolar electrocautery probe was used to penetrate the ovarian capsule at 4 points (regardless of the size of the ovary), with the aid of a short burst of monopolar diathermy. The probe (which has a distal stainless steel needle measuring 10 mm in length and 2 mm in diameter) was applied to the surface of the ovary at a right angle to avoid slippage and to minimize surface damage. A monopolar coagulating current at a 40 W power setting was used. The needle was pushed through the ovarian capsule for about 4 mm depth into the ovarian tissue and electricity was activated for 4 seconds. The ovary was then cooled using 200 ml crystalloid solution before releasing the ligament.

Follow up:

Total testosterone and blood flow assessment (PI - RI) of the subendometrial region were performed again in the early follicular phase (days 2-4 of the menstrual cycle) of the first post-operative spontaneous menstruation (which occurred within 10 weeks after the operation).

Also, patients were followed to detect ovulation. ovulating patients were followed for 6 months to detect pregnancy.

详细描述

Effect of Laparoscopic Ovarian Drilling on Subendometrial Blood Flow in Women with Polycystic Ovary Syndrome

Patients and methods:

This interventional study was carried out in the Department of Obstetrics and Gynecology (Infertility, Ultrasound and Gynecologic endoscopy units), Faculty of Medicine, Zagazig University Hospitals in the period between July 2016 and October 2017. The study included 200 infertile women (primary or secondary infertility) with PCOS attended the infertility outpatient clinic and fulfilled the following inclusion criteria: 1- Patients' ages 20 to 34 years; 2- BMI 18-25 kg/m2; 3- PCOS was diagnosed according to Rotterdam criteria, 2003 (two criteria are sufficient for diagnosis of PCOS): (i) oligo-and/or an-ovulation; which is manifested clinically by amenorrhoea or oligomenorrhoea, (ii) hyperandrogenism (clinical and/or biochemical); (hirsutism and/or elevated serum level of total testosterone), (iii) polycystic ovaries by ultrasound (each ovary contains 12 or more follicles measuring 2-9 mm and/ or ovarian volume more than 10 ml), ( we included only patients who had the three criteria of PCOS) , and previously documented anovulation by transvaginal ultrasound follicular monitoring while taking incremental doses of clomiphene citrate (clomiphene citrate resistant); 4- Hysterosalpingography and husband semen analysis were normal in all subjects. 5- All women in the study were free of any medical illness and had not received any medications in the last 6-9 months before the study apart from clomiphene citrate.

Exclusion criteria were: 1- Other PCOS like syndromes (late onset congenital adrenal hyperplasia-androgen producing tumors-Cushing,s syndrome), hyperprolactinemia and thyroid abnormalities; 2- Gross ovarian pathology either diagnosed preoperatively by ultrasound or intraoperatively by laparoscopy; 3- Any uterine pathology diagnosed preoperatively by ultrasound, HSG or hysteroscopy; or intraoperatively by endoscopy and suspected to cause infertility; 3- Other causes of infertility even if diagnosed during laparoscopy such as tubal pathology and pelvic endometriosis or adhesions; 4- Previous uterine, tubal or ovarian surgery. 5- Contraindications to laparoscopy and general anesthesia; 6- Pregnancy before the first post-operative menstrual cycle.

After full detailed history taking, general, abdominal and local examination and exclusion of any associated medical disorders, transabdominal and/or transvaginal ultrasound was done to exclude patients with ovarian or pelvi-abdominal masses. Other investigations were done to fulfill the inclusion and exclusion criteria (serum prolactin level, free T3, free T4, TSH). Serum level of total testosterone was measured in the early follicular phase (days 2-4 of spontaneous cycle in oligomenorrhic patients). To start the study in amenorrhic patients (after exclusion of pregnancy) they received progesterone (oral Norethisterone Acetate 10 mg daily for 5 days) to induce withdrawal bleeding and total testosterone was measured in days 2-4 of this withdrawal bleeding. Total testosterone was done for all patients in the Laboratory of Zagazig University Hospitals by Electrochemiluminescence (ECL) technology (Cobas e 411 analyzer-Roche Diagnostics GmbH-D-68298 Mannheim-Germany).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 34 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients' ages 20 to 34 years.
  • BMI 18-25 kg/m
  • PCOS was diagnosed according to Rotterdam criteria, 2003 (two criteria are sufficient for diagnosis of PCOS): (i) oligo-and/or an-ovulation; which is manifested clinically by amenorrhoea or oligomenorrhoea, (ii) hyperandrogenism (clinical and/or biochemical); (hirsutism and/or elevated serum level of total testosterone), (iii) polycystic ovaries by ultrasound (each ovary contains 12 or more follicles measuring 2-9 mm and/ or ovarian volume more than 10 ml), ( we included only patients who had the three criteria of PCOS) , and previously documented anovulation by transvaginal ultrasound follicular monitoring while taking incremental doses of clomiphene citrate (clomiphene citrate resistant).
  • Hysterosalpingography and husband semen analysis were normal in all subjects.
  • All women in the study were free of any medical illness and had not received any medications in the last 6-9 months before the study apart from clomiphene citrate.

排除标准

  • Other PCOS like syndromes (late onset congenital adrenal hyperplasia-androgen producing tumors-Cushing,s syndrome), hyperprolactinemia and thyroid abnormalities.
  • Gross ovarian pathology either diagnosed preoperatively by ultrasound or intraoperatively by laparoscopy.
  • Any uterine pathology diagnosed preoperatively by ultrasound, HSG or hysteroscopy; or intraoperatively by endoscopy and suspected to cause infertility.
  • Other causes of infertility even if diagnosed during laparoscopy such as tubal pathology and pelvic endometriosis or adhesions.
  • Previous uterine, tubal or ovarian surgery.
  • Contraindications to laparoscopy and general anesthesia.
  • Pregnancy before the first post-operative menstrual cycle.

研究组 & 干预措施

polycystic ovary syndrome patients

Experimental

patients with polycystic ovary syndrome performed laparoscopic ovarian drilling to induce ovulation

干预措施: Laparoscopic ovarian drilling (Procedure)

结局指标

主要结局

Subendometrial blood flow

时间窗: Within 10 weeks

change in Subendometrial blood flow after laparoscopic ovarian drilling

次要结局

  • Ovulation(Within 10 weeks)
  • Pregnancy(Within 6 months)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Mostafa Abdo Ahmed

Principal Investigator

Zagazig University

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