Laparoscopic Ovarian Drilling Versus Gonadotrophins for Anovulatory Polycystic Ovary Syndrome Resistant to First Line Ovulation Induction: a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 主要终点
- Live Birth
研究概览
简要总结
PCOS is a complex disease that is diagnosed by the presence of two of the following three: oligo/anovulation, clinical and/or biochemical hyperandrogenism, or polycystic ovaries by ultrasound . PCOS affects 4% to 21% of females in reproductive age . Although subfertility is abundant in women with PCOS, a majority of these women will achieve pregnancy naturally or by treatment.
Different treatment modalities are present for ovulation induction. Life style modifications including weight loss are encouraged for those who are overweight or obese. Pharmacological induction of ovulation represent the first line therapy for induction of ovulation. Options include aromatase inhibitors (Letrozole), Clomiphene Citrate (CC) or Metformin, alone or in combinations.
For second line treatment either Gonadotropins (Gn) or laparoscopic ovarian surgery (LOS) are the recommended options .
the objective of the trial is to study the effectiveness and safetey of surgical induction of ovulation strategy and compare it to medical induction strategy with Gonadotropins
详细描述
PCOS is a complex disease that is diagnosed by the presence of two of the following three: oligo/anovulation, clinical and/or biochemical hyperandrogenism, or polycystic ovaries by ultrasound . PCOS affects 4% to 21% of females in reproductive age . Although subfertility is abundant in women with PCOS, a majority of these women will achieve pregnancy naturally or by treatment.
Different treatment modalities are present for ovulation induction. Life style modifications including weight loss are encouraged for those who are overweight or obese. Pharmacological induction of ovulation represent the first line therapy for induction of ovulation. Options include aromatase inhibitors (Letrozole), Clomiphene Citrate (CC) or Metformin, alone or in combinations.
For second line treatment either Gonadotropins (Gn) or laparoscopic ovarian surgery (LOS) are the recommended options .
Systematic reviews done comparing LOD to Gn found no differences in live birth, clinical pregnancy or miscarriage rates. However, there was significant decrease in OHSS and multiple pregnancies with LOD . Giving these advantages together with being cheap, the surgical strategy may be a more favorable choice as second line treatment of anovulation . Also several randomised controlled trial (RCTs) reported normalization of ovarian reserve parameters after LOD, making it a long-lasting option compared to the one-cycle effect of medical treatment the objective of the trial is to study the effectiveness and safetey of surgical induction of ovulation strategy and compare it to medical induction strategy with Gonadotropins
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
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •anovulatory polycystic ovary syndrome resistant to first line ovulation induction.
- •Polycystic ovary Syndrome defined by Rotterdam's criteria 2003
- •Clomiphene resistance defined as failure to ovulate with a dose of 150mg per day for 5 days for 3 cycles
- •Letrozole resistance defined as failure to ovulate with a dose of 7.5 mg per day for 5 days for 3 cycles
排除标准
- •women's age < 18 years or ≥ 40 years.
- •BMI > 40 kg/m2
- •Patient with hyperprolactinaemia (serum prolactin above normal limits)
- •Patients with hypogonadotropic hypogonadism (low serum FSH and LH)
- •Patients with anovulation due to ovarian failure (serum FSH higher than normal limits)
- •Male infertility
- •Tubal abnormality, Known endometriosis, adenomyosis, uterine myomas or any other detected cause of female infertility
- •History of ovarian surgery as laparoscopic ovarian drilling, ovarian cystectomy or oophorectomy
- •History of pelvic radiation
- •Patient recently treated with any type of induction of ovulation in the last three months.
研究组 & 干预措施
Surgical treatment strategy:
干预措施: Laparoscopic ovarian drilling (Procedure)
Gonadotrophins treatment strategy
干预措施: Recombinant FSH (rFSH) (Drug)
结局指标
主要结局
Live Birth
时间窗: within 12 months after of end treatment strategy
defined as the number of births resulted in live babies after the age of viability (24th week of pregnancy)
次要结局
未报告次要终点
研究者
Khaled Mustafa Attyia
Principal Investigator
Assiut University