Should clomiphene citrate (CC) or low-dose gonadotrophin therapy be the first-line treatment for anovulatory infertility associated with polycystic ovary syndrome (PCOS)? A multicentre, randomised, prospective study and cost effective analysis.

VU University Medical Centre (VUMC) (Netherlands)0 个研究点目标入组 320 人开始时间: 2006年2月14日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. The diagnosis of PCOS will be made when a history of at least 6 months inability to conceive is accompanied by at least 2 of the following:
•1.1. Irregular menstruation (oligo- or amenorrhea) (>35 days)
•1.2. Clinical or biochemical evidence of hyperandrogenism (hirsutism, acne, raised TT or FAI)
•1.3. Typical features of PCO on ultrasound (U/S) examination (see The Rotterdam Consensus for further details)
•2. All women desiring pregnancy who conform to the definition of PCOS cited above and who have had no fertility treatment in the preceding year
•3. Age <40 years
•4. Patients who have previously conceived either spontaneously or on CC therapy may also be included
•5. Patients with a previous history of pregnancy, whether resulting in a delivery or spontaneous abortion, a previous history of gynecological or abdominal surgical intervention or pelvic inflammatory disease, should have a normal uterine cavity and tubal patency demonstrated by radiological (HSG), laparoscopic or ultrasonic means before entering the study
•6. A mandatory sperm count deemed normal by the treating physician is acceptable for inclusion. Intrauterine insemination may be employed at the discretion of the treating physician.

•1. Age >39 years
•2. An obvious mechanical or male factor
•3. Co-existing conditions such as overt diabetes mellitus, oestrogen dependent tumours, ovarian cysts, hypertension, thyroid disease, Cushing?s syndrome or congenital adrenal hyperplasia

发起方

VU University Medical Centre (VUMC) (Netherlands)