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

VU University Medical Center, Devision of Reproductive Medicine0 个研究点目标入组 320 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

•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. Irregular menstruation (oligo- or amenorrhea)(>35 days);
•2. Clinical or biochemical evidence of hyperandrogenism (hirsutism, acne, raised TT or FAI);
•3. Typical features of PCO on U/S examination (see The Rotterdam Consensus for further details);
•- All women desiring pregnancy who conform to the definition of PCOS cited above and who have had no fertility treatment in the preceding year;
•- Age <40 years;
•- Patients who have previously conceived either spontaneously or on CC therapy may also be included;
•- 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;
•- 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;
•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 Center, Devision of Reproductive Medicine