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.
- Conditions
- Polycystic Ovary Syndrome (PCOS)Urological and Genital DiseasesOvarian dysfunction
- Registration Number
- ISRCTN41865643
- Lead Sponsor
- VU University Medical Centre (VUMC) (Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 320
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Pregnancy rate - per patient, per cycle, cumulative over 3 cycles (hCG measurement 15 days after ovulation)<br>2. Miscarriage rate - embryonic, fetal (diagnosed with ultrasound)<br>3. Multiple pregnancy rate (number of gestational sacs measured with ultrasound)<br>4. Live birth rate<br>5. Ovulation rate (followed with ultrasound)<br>6. Initiation of treatment to pregnancy interval
- Secondary Outcome Measures
Name Time Method 1. Number and size of follicles >10 mm on day of hCG<br>2. Endometrial thickness on day of hCG<br>3. Estradiol and progesterone concentrations on day of hCG<br>4. Number of abandoned cycles (hCG withheld) due to overstimulation or lack of response<br>5. Ovarian hyperstimulation<br>6. Correlation of basal hormone concentrations with pregnancy and miscarriage rates<br>7. Number of units of Puregon used per cycle and per pregnancy achieved