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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.


- candidate number1887
- NTR NumberNTR545
- ISRCTNISRCTN41865643
- Date ISRCTN created14-feb-2006
- date ISRCTN requested13-jan-2006
- Date Registered NTR13-dec-2005
- Secondary IDs04.165 
- Public TitleShould 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.
- Scientific TitleShould 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.
- ACRONYMCOFFI study
- hypothesisWe hypothesize that the use of low dose gonadotrophin therapy, will prove to be more efficient than CC when used as first line treatment.
- Healt Condition(s) or Problem(s) studiedPolycystic ovary syndrome (PCOS)
- Inclusion criteriaThe 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.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-nov-2004
- planned closingdate1-nov-2008
- Target number of participants320
- InterventionsMedications. Patients will be randomized to receive either Clomiphene citrate or Puregon (Follitropine/ r-FSH) for ovulation induction (A maximum of 3 cycles of treatment will be given for the purposes of this study). Clomiphene citrate will be given starting on day 4 of the cycle for 5 days. If no response is seen by day 17 of the cycle, it should be abandoned. Puregon (follitropine) will be given, starting from day 4 of the cycle, until the criteria for hCG administration are achieved. If these criteria are not reached following 35 days of stimulation, the cycle should be abandoned Monitoring. An U/S examination of follicle number and size and endometrial thickness will be performed. HCG will be given when at least 1 follicle of >17mm are seen on U/S examination. This applies to both treatment protocols. HCG will be witheld if a total of >3 follicles >15mm diameter are seen on U/S.
- Primary outcome1. Pregnancy rate – per patient, per cycle, cumulative over 3 cycles (hCG measurement 15 days after ovulation); 2. Miscarriage rate – embryonic, fetal (diagnosed with ultrasound); 3. Multiple pregnancy rate (number of gestational sacs measured with ultrasound); 4. Live birth rate; 5. Ovulation rate (followed with ultrasound); 6. Initiation of treatment to pregnancy interval.
- Secondary outcome1. Number and size of follicles >10mm on day of hCG; 2. Endometrial thickness on day of hCG; 3. Estradiol and progesterone concentrations on day of hCG; 4. Number of abandoned cycles (hCG witheld) due to overstimulation or lack of response; 5. Ovarian hyperstimulation; 6. Correlation of basal hormone concentrations with pregnancy and miscarriage rates; 7. Number of units of Puregon used per cycle and per pregnancy achieved.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. R. Homburg
- CONTACT for SCIENTIFIC QUERIESProf. R. Homburg
- Sponsor/Initiator VU University Medical Center, Department of Obstetrics and Gynaecology
- Funding
(Source(s) of Monetary or Material Support)
Stichting Wetenschappelijk Onderzoek Gynaecologie (SWOG)
- PublicationsN/A
- Brief summaryA multicentre, randomized, open, prospective trial and cost effective analysis. Infertile women with established PCOS who have had no infertility treatment in the preceding 12 months and who have never received FSH, will be randomized to receive either CC or FSH for a maximum of 3 cycles.
- Main changes (audit trail)
- RECORD13-dec-2005 - 6-mrt-2006


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