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)

niversity of Birmingham0 个研究点目标入组 1,700 人开始时间: 2020年1月7日最近更新: 2024年3月4日

试验速览

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•Current inclusion criteria as of 17/10/2022:
•1. Women diagnosed with PCOS (according to Rotterdam criteria) 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 20 nmol/l 7 days prior to a period)
•2. Presentation with infertility or wishing to conceive
•3. Male partner with normal sperm count (=15 million per milliliter (mL)) and progressive motility =32% or total motility of more than =40% in the last 3 years
•4. Willing and able to give informed consent
•5. Aged =>18 to <=42 years at randomisation
•6. Body Mass Index <=35 kg/m2
•Previous inclusion criteria:
•1. Women diagnosed with PCOS (according to Rotterdam criteria) 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)
•2. Presentation with infertility or wishing to conceive
•3. Male partner with normal sperm count (>=15 million) and progressive motility (>= 32%) in the last 3 years
•4. Willing and able to give informed consent

•Current exclusion criteria as of 17/10/2022:
•1. More than six previous ovulation induction treatments (cycles) with either letrozole or clomifene in the previous 12 months
•2. Intention to continue current use of metformin treatment for ovulation induction or for other indications
•3. Metformin use in the previous 14 days
•4. 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
•5. Contraindications to letrozole, clomifene, metformin use and/or pregnancy
•6. Woman has previously participated in the LOCI trial
•Previous exclusion criteria:
•1. Age <18 or >43 years at randomisation
•2. Body Mass Index =35 kg/m²
•3. Three or more previous ovulation induction treatments with either letrozole or clomifene
•4. Currently on metformin treatment or inositol supplements for ovulation induction or for other indications
•5. 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
•6. Contraindications to letrozole, clomifene, metformin use and/or pregnancy (see section 7.2 for full details on contraindications)
•7. Woman has previously participated in the LOCI trial

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