Condition category
Pregnancy and Childbirth
Date applied
26/08/2010
Date assigned
28/03/2011
Last edited
28/03/2011
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

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 measures

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes