跳至主要内容
临床试验/NCT02304536
NCT02304536Unknown3 期

Comparison Between Laproscopic Ovarian Diathermy and Urinary Purified FSH in Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome: A Randomised Controlled Trial

Cairo University2 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2014年11月最近更新:
适应症
干预措施

试验速览

阶段
3 期
入组人数
210
试验地点
2
主要终点
Ovulation

研究概览

简要总结

210 women with clomiphene resistant PCOS will be randomly divided into 3 equal groups using computer generated random numbers. Group 1 will receive combined metformin and FSH, group 2 will have LOD and group 3 will act as the control group with no intervention.

详细描述

Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in reproductive age, with an incidence of 5 -10% . Classically clomiphene citrate (CC) is the first approach to induce ovulation in patients with PCOS. Although 70-80% of PCOS women can ovulate by the treatment with CC, only 40%of the PCOS women become pregnant. Women who do not ovulate with increasing doses of CC are described as being CC-resistant and remain a major challenge in gynecologic endocrinology. Traditional alternatives for CC-resistant patients include gonadotropin therapy and laparoscopic ovarian diathermy.

Gonadotropin therapy is widely used for ovulation induction in CC-resistant PCOS patients. The use of purified FSH preparation virtually free of LH activity, is a recommendable treatment since there is evidence that pure FSH may significantly reduce tonic LH levels, favourably alter the intraovarian hormonal milieu, and promote the initial follicular development with minimal risk of multiple follicular growth or ovarian hyperstimulation .

The use of metformin in PCOS is associated with cycle regulation, improved ovulation, and a reduction in circulating androgen levels (5). Metformin likely plays its role in improving ovulation induction in women with PCOS through a variety of actions, including reducing insulin levels and altering the effect of insulin on ovarian androgen biosynthesis, theca cell proliferation, and endometrial growth. In addition, potentially through a direct effect, it inhibits ovarian gluconeogenesis and thus reduces ovarian androgen production .

Laparoscopic ovarian drilling (LOD) can avoid or reduce the need for gonadotropins for ovulation induction. Several potential mechanisms of action of LOD have also been suggested. The reduction of inhibin production following LOD is followed by an increase in FSH secretion and recruitment of a new cohort of follicles. Other theory is restoration of normal production of the putative gonadotropin surge after laparoscopic ovarian electrocautery. Moreover, drainage of androgens and inhibin from follicles surface may inhibit the excessive collagenisation of overlying ovarian cortex and facilitate Softening of ovarian tunica. Neighbouring follicles that are not undergoing atresia may then mature and gain access to the ovarian surface, facilitating ovulation. Initiation of normal inhibin B pulsatility by LOD appears to correlate with the postoperative onset of ovulatory cycles (3).

The main drawbacks of LOD are adhesions formation and ovarian atrophy. That is why minimising the number of diathermy points and avoiding diathermy near the ovarian hilum are recommended.

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 (Care Provider)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Clomiphene resistant PCOS

排除标准

  • Other causes of infertility
  • Hyperprolactinaemia.
  • Allergy to FSH.

研究组 & 干预措施

FSH

Active Comparator

will receive urinary purified FSH (Fostimon® IBSA, Switzerland) 75IU daily for 7 days starting from the 3rd day of menstruation or progesterone withdrawal bleeding. If the follicle does not exceed 9mm the dose will be increased by 37.5IU every 7 days. The cycle will be cancelled if no follicles exceed 9mm 4 weeks after starting FSH. This was combined with oral metformin (Cidophage® CID, Egypt) 500 mg three times per day.

干预措施: FSH (Drug)

Ovarian drilling

Active Comparator

70 women will have laparoscopic ovarian drilling in which the ovaries will be stabilised by grasping the ovarian ligament and monopolar diathermy will be used to do 4-10 punctures in each ovary. The number of punctures will be individualised according to the size of the ovary. Serial vaginal ultrasound scans were done starting from the 10th day of menstruation, the frequency of monitoring will be individualized according to the women's response.

干预措施: Laparoscopic ovarian drilling (Procedure)

结局指标

主要结局

Ovulation

时间窗: 6 weeks after starting the intervention

Vaginal sonography will be done regularly to check ovulation.

次要结局

  • Proportion of women getting pregnant(6 months after starting the intervention)

研究者

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

AbdelGany Hassan

Lecturer of Gynecology and Obstetrics

Cairo University

研究点 (2)

Loading locations...

相似试验