Clomiphene Citrate for Poor Responder women undergoing in vitro fertilisation (IVF)/intracytoplasmic sperm injection (ICSI) treatment cycles
| ISRCTN | ISRCTN58828341 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58828341 |
| Secondary identifying numbers | N/A |
- Submission date
- 26/08/2010
- Registration date
- 28/03/2011
- Last edited
- 28/03/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
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
Dr Mohamed Youssef
Scientific
Scientific
Egyptian International Fertility and IVF Center (EIFC)
Cairo
-
Egypt
| m.a.ypossef@amc.uva.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Clomiphene Citrate for Poor Responder women undergoing in vitro fertilisation (IVF)/intracytoplasmic sperm injection (ICSI) treatment cycles: randomised controlled study |
| Study acronym | CCPR |
| Study objectives | 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(s) | The ethics board of the Egyptian International Fertility and IVF Center (EIFC) approved in March 2003 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/04/2008 |
| Completion date | 01/01/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 70 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/04/2008 |
| Date of final enrolment | 01/01/2009 |
Locations
Countries of recruitment
- Egypt
Study participating centre
Egyptian International Fertility and IVF Center (EIFC)
Cairo
-
Egypt
-
Egypt
Sponsor information
Egyptian International Fertility and IVF Center (EIFC) (Eygpt)
Hospital/treatment centre
Hospital/treatment centre
c/o Mohamed Abdel Fattah Mahmoud Youssef
Cairo
-
Egypt
| m.a.youssef@amc.uva.nl | |
"ROR" |
https://ror.org/035aahr55 |
Funders
Funder type
Other
Investigator initiated and funded (Egypt)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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 |
