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.
- Conditions
- polycystic ovary syndrome (PCOS)
- Registration Number
- NL-OMON29131
- Lead Sponsor
- VU University Medical Center, Devision of Reproductive Medicine
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 320
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method