Contact information
Type
Scientific
Primary contact
Dr Mohamed Youssef
ORCID ID
Contact details
Egyptian International Fertility and IVF Center (EIFC)
Cairo
-
Egypt
m.a.ypossef@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Clomiphene Citrate for Poor Responder women undergoing in vitro fertilisation (IVF)/intracytoplasmic sperm injection (ICSI) treatment cycles: randomised controlled study
Acronym
CCPR
Study hypothesis
Mild stimulation in the form of combined administration of oral clomiphene citrate (CC), follicle stimulating hormone (FSH), and gonadotrophin-releasing hormone (GnRH) antagonist (fixed protocol) preceded by luteal estradiol, for poor responders elected for assisted reproduction techniques (ART) could achieve comparable outcomes in comparison with the standard long protocol.
Ethics approval
The ethics board of the Egyptian International Fertility and IVF Center (EIFC) approved in March 2003
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Poor ovarian response
Intervention
Control group:
Thirty-five women underwent COH with a long GnRH agonist protocol: Triptorelin acetate SC (Decapeptyl® 0.1 mg, Ferring, Denmark) was administrated in the midluteal phase at a daily dose of 0.1 mg of the preceding cycle. Two weeks later, once desensitisation was achieved (E2 less than or equal to 50 pg/ml, no evidence of ovarian cysts on ultrasound and endometrial thickness less than 5 mm), ovarian stimulation with subcutaneous (s.c.) highly purified HMG Menopur® (Ferring, Denmark) 300 IU daily was commenced. Decapeptyl® was continued until the day of HCG administration.
Study group:
Thirty - five women received Luteal E2 (ethinylestradiol 2 mg [Progynova®]) two tablets daily was given till menstruation. Transvaginal ultrasound and serum progesterone were arranged on day 2 of the period. After confirmation of quiescent ovaries, 100 mg clomophene citrate was given from day 2 to 6 of the menstruation. HP HMG Menopur® (Ferring, Denmark) 3 ampoules daily from day 7, (225 IU). GnRH antagonist, cetrorelix 0.25 mg s.c. (Cetrotide® Serono Laboratories, Aubonne, Switzerland) has been given on day 6 of stimulation (fixed protocol) to prevent premature lutenisation, until the day of HCG administration.
The total duration of the intervention is 2-3 weeks. The total duration of follow up is 1-3 months.
Intervention type
Drug
Phase
Not Specified
Drug names
Triptorelin acetate SC (Decapeptyl® ), highly purified Human Menopausal Gonadotrophin (HMG) Menopure®, Progynova® ethinylestradiol, clomophene citrate, cetrorelix
Primary outcome measure
1. Duration of stimulation (i.e. duration and amount of HMG used)
2. Consumption of gonadotrophins
3. Cycle cancellation rate
4. Number of mature follicles recruited
5. Total oocytes retrieved
Secondary outcome measures
1. Laboratory outcomes
2. Implantation rate
3. Clinical pregnancy rates, 7 weeks from positive pregnancy test
Overall trial start date
01/04/2008
Overall trial end date
01/01/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Women 20 - 42 years old
2. History of primary or secondary infertility (defined as the inability to conceive after 2 years of unprotected intercourse)
3. Normal menstrual cycle
4. Body mass index (BMI) less than 27 kg/m^2
5. Not taking medication for at least 1.5 months
6. Both ovaries are present
7. Basal FSH level on day 3 is less than 10 IU/L
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
70
Participant exclusion criteria
1. Clinically or medically significant systemic disease
2. Hypothalamic amenorrhoea
3. Cycle cancellation due to poor ovarian response; patients were defined as poor responders by number of dominant follicles on HCG day and number of mature oocytes less than 3
Recruitment start date
01/04/2008
Recruitment end date
01/01/2009
Locations
Countries of recruitment
Egypt
Trial participating centre
Egyptian International Fertility and IVF Center (EIFC)
Cairo
-
Egypt
Sponsor information
Organisation
Egyptian International Fertility and IVF Center (EIFC) (Eygpt)
Sponsor details
c/o Mohamed Abdel Fattah Mahmoud Youssef
Cairo
-
Egypt
m.a.youssef@amc.uva.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded (Egypt)
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
Basic results (scientific)
Publication list