etrozole or Clomifene, with or without metformin, for ovulation induction in women with polycystic ovary syndrome: a 2x2 factorial design randomised trial (The LOCI trial) - LOCI: Letrozole Or Clomifene for Ovulation Induction

niversity of Birmingham0 个研究点目标入组 2,100 人开始时间: 2019年12月19日最近更新: 2020年5月4日

适应症

试验速览

暂无简介。

•?Women diagnosed with PCOS (according to Rotterdam criteria)13 and evidence of anovulation (anovulation is defined as irregular cycles lasting <21 or more than 35 days or less than 8 periods per year OR absence of raised serum progesterone greater than 20nmol/l 7 days prior to a period);
•?Presentation with infertility or wishing to conceive;
•?Male partner with normal sperm count (= 15 million) and progressive motility (= 32%) in the last 3 years;
•?Willing and able to give informed consent.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 2100
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•?Age =18 or =43 years at randomisation;
•?Body Mass Index =35;
•?Three or more previous ovulation induction treatments with either letrozole or clomifene;
•?Intention to continue current use of metformin treatment or inositol supplements for ovulation induction or for other indications
•?Metformin or inositol supplement use in the previous 3 months
•?Women opting for alternative methods of ovulation induction or treatment (GnRH agonists and antagonists, gonadotropins), triggering ovulation with hCG, or performing intrauterine or intracervical insemination;
•?Contraindications to letrozole, clomifene, metformin use and/or pregnancy (see section 7.3 for full details on contraindications).
•?Woman has previously participated in the LOCI trial.

发起方