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.
ISRCTN | ISRCTN41865643 |
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DOI | https://doi.org/10.1186/ISRCTN41865643 |
Secondary identifying numbers | NTR545; 04.165 |
- Submission date
- 14/02/2006
- Registration date
- 14/02/2006
- Last edited
- 25/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof R. Homburg
Scientific
Scientific
VU University Medical Center
Department of Obstetrics and Gynaecology Division of Reproductive Medicine
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
Phone | +31 (0)20 4440070 |
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R.homburg@vumc.nl |
Study information
Study design | Multicentre randomised open label active controlled parallel group prospective study and cost effective analysis |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study acronym | COFFI study |
Study objectives | We hypothesize that the use of low dose gonadotrophin therapy, will prove to be more efficient than CC when used as first line treatment. |
Ethics approval(s) | Received from local medical ethics committee |
Health condition(s) or problem(s) studied | Polycystic Ovary Syndrome (PCOS) |
Intervention | Medications: Patients will be randomised to receive either clomiphene citrate or Puregon (Follitropine/ recombinant - Follicule Stimulating Hormone [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 human Choionic Gonadotropin (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 >17 mm is seen on U/S examination. This applies to both treatment protocols. HCG will be withheld if a total of >3 follicles >15 mm diameter are seen on U/S. |
Intervention type | Other |
Primary outcome measure | 1. 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 outcome measures | 1. Number and size of follicles >10 mm 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 withheld) 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 |
Overall study start date | 01/11/2004 |
Completion date | 01/11/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | 320 |
Key inclusion criteria | 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. |
Key exclusion criteria | 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, Cushings syndrome or congenital adrenal hyperplasia |
Date of first enrolment | 01/11/2004 |
Date of final enrolment | 01/11/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
VU University Medical Center
Amsterdam
1007 MB
Netherlands
1007 MB
Netherlands
Sponsor information
VU University Medical Centre (VUMC) (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Obstetrics and Gynaecology
Division of Reproductive Medicine
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
https://ror.org/00q6h8f30 |
Funders
Funder type
Charity
Gynaecology Research Foundation (Stichting Wetenschappelijk Onderzoek Gynaecologie [SWOG]) (Netherlands)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |