跳至主要内容
临床试验/NCT04021940
NCT04021940Unknown不适用

A Randomized Comparison of Dose Adjusted vs. Fixed Dose Unilateral Laparoscopic Ovarian Drilling in Polycystic Ovary Syndrome Patients

Hatem AbuHashim0 个研究点目标入组 128 人开始时间: 2019年8月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
128
主要终点
ovulation rate

研究概览

简要总结

Polycystic ovary syndrome (PCOS) is a common endocrine disorder and a leading cause of infertility in women of reproductive age affecting up to 20% of them. Laparoscopic ovarian drilling (LOD) is considered a second-line treatment of infertile patients with clomiphene citrate-resistant (CCR) PCOS i.e. those who did not ovulate in response to CC doses of up to 150 mg for at least three consecutive cycles. The advantage of LOD is the induction of unifollicular ovulation without the risk of ovarian hyperstimulation syndrome or high-order multiple pregnancies.

The common practice of LOD was to drill both ovaries i.e. bilateral (BLOD) with a fixed dose of 600 Joules per each ovary (1200 Joules in both) delivered through four punctures, each for 4 s and using 40 W. However, its main adverse effect is diminished ovary reserve due to tissue damage (2). In 1994, Balen and Jacobs reported the effectiveness of fixed-dose unilateral LOD (ULOD) in the management of those women. Subsequently, several randomized trials demonstrated its efficacy with comparable ovulation and pregnancy rates to BLOD.

Recently, a new concept called"dose-adjusted" ULOD was proposed. It means to tailor the energy applied to one ovary, according to its preoperative volume using 60 J/ cm3. When compared with the fixed-dose BLOD among 96 infertile women with CCR- PCOS, a significantly higher ovulation rate during the first postoperative menstrual cycle was in favor of the ULOD group (73 vs. 49%). Meanwhile, a comparable ovulation rate over the 6-month period was found (82 vs. 64%) (6). In addition, both groups experienced a reduction in serum anti-mullerian hormone (AMH) level after LOD which was significantly more in the BLOD group in the first and the 6-month follow-up periods. However, another RCT (n=108 CCR- PCOS patients) reported a comparable ovulation and pregnancy rates at 3-month follow-up period (65.4 vs. 77.3% and 15.4 vs. 26.4%, in ULOD and BLOD respectively) with a reduction in the effectiveness of dose-adjusted ULOD after 6 months. A highly significant difference between ULOD and BLOD groups with regard to the AMH level at 3- and 6-month was also reported. Thereby, the efficacy of dose-adjusted ULOD in improving fertility outcomes in infertile women with CCR- PCOS as well as its effect on ovarian reserve warrants more investigation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

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

  • Diagnosis of PCOS will be based on the revised 2003 consensus on diagnostic criteria and long-term health risks related to PCOS and its modification (ESHRE, 2018).
  • CCR will be considered if persistent anovulation with 150 mg CC daily for 5 days per cycle, for at least three cycles.
  • Only patients with a phenotype characterized by oligomenorrhoea/anovulation, hyperandrogenaemia and polycystic ovaries on ultrasound examination (PCOM) and a phenotype characterized by oligomenorrhoea/anovulation and PCOM will be enrolled in the study.
  • Age: 20-34 years.
  • Body mass index < 30 kg/m2
  • Patent fallopian tubes by hysterosalpingography.
  • Normal semen analysis of husbands.

排除标准

  • Age ≥ 35 years.
  • Previous history of LOD
  • PCOS phenotypes with regular menses or without PCOM ovaries on USS.
  • Other causes of infertility
  • Women with adrenal hyperplasia, thyroid disease, Cushing's syndrome, hyperprolactinemia and a tumor-related excess of androgen.

研究组 & 干预措施

Dose adjusted ULOD

Experimental

dose adjusted ULOD using 60J/cm3 applied to the larger ovary. The number of punctures (Np) per ovary will be calculated according to the following formula: Np = 60 J/cm3 divided by 30 W x 4 s.

干预措施: ULOD (Procedure)

Fixed dose ULOD

Active Comparator

600 J for the larger ovary will be delivered through four punctures, each for 4 s and 40 W

干预措施: ULOD (Procedure)

结局指标

主要结局

ovulation rate

时间窗: At 6 months postoperative

serum progesterone level \>5 ng/mL on D 21 of the cycle

次要结局

未报告次要终点

研究者

发起方
Hatem AbuHashim
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hatem AbuHashim

Professor

Mansoura University

相似试验

Dose Adjusted vs. Fixed Dose Unilateral Laparoscopic... | 临床试验