Condition category
Urological and Genital Diseases
Date applied
14/02/2006
Date assigned
14/02/2006
Last edited
25/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof R. Homburg

ORCID ID

Contact details

VU University Medical Center
Department of Obstetrics and Gynaecology Division of Reproductive Medicine
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
+31 (0)20 4440070
R.homburg@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR545; 04.165

Study information

Scientific title

Acronym

COFFI study

Study hypothesis

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

Received from local medical ethics committee

Study design

Multicentre randomised open label active controlled parallel group prospective study and cost effective analysis

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/11/2004

Overall trial end date

01/11/2008

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

320

Participant 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, Cushing’s syndrome or congenital adrenal hyperplasia

Recruitment start date

01/11/2004

Recruitment end date

01/11/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

VU University Medical Center
Amsterdam
1007 MB
Netherlands

Sponsor information

Organisation

VU University Medical Centre (VUMC) (Netherlands)

Sponsor details

Department of Obstetrics and Gynaecology
Division of Reproductive Medicine
P.O. Box 7057
Amsterdam
1007 MB
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Gynaecology Research Foundation (Stichting Wetenschappelijk Onderzoek Gynaecologie [SWOG]) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes