Extended Letrozole Regimen Co-treatment With Gonadotropin Releasing Hormone Antagonist Protocol Versus Gonadotropin Releasing Hormone Antagonist Protocol in Poor Responders Undergoing IVF-ET
1 other identifier
interventional
106
1 country
2
Brief Summary
The object of this study is to evaluate the efficacy of extended letrozole co-treatment with GnRH-antagonist protocol in ovarian stimulation of poor responder patients undergoing IVF-ET.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2018
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2018
CompletedFirst Submitted
Initial submission to the registry
February 12, 2020
CompletedFirst Posted
Study publicly available on registry
February 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2020
CompletedFebruary 13, 2020
February 1, 2020
2 years
February 12, 2020
February 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of oocytes retrieved
Oocytes aspirated during ovum pickup
Three weeks after start of ovarian stimulation
Study Arms (2)
GnRH ant/letrozole
EXPERIMENTALLetrozole (Femara; Novertis pharma AG, Basle, Switzerland) is administered starting on cycle day one for 8 consecutive days . The dose of letrozole is 5mg /day during the first 5 days of cycle and 2.5 mg/day during the subsequent 3 days . Highly purified urinary FSH (HP-uFSH) (Fostimon, IBSA) 300 IU/day is started on cycle day 5 and is continued until and including the day of HCG administration. Starting from cycle day 8 , the dose of HP-uFSH is adjusted individually according to ovarian response which is monitored using transvaginal ultrasound and serum estradiol. GnRH antagonist (cetrorelix acetate)(Cetrotide®) 0.25 mg S.C once daily is started when the leading follicle is 14 mm in mean diameter and is continued until and including the day of HCG administration .
GnRH ant
ACTIVE COMPARATORHighly purified urinary FSH (HP-uFSH) (Fostimon, IBSA) 300 IU/day is started on cycle day 5 and is continued until and including the day of HCG administration. Starting from cycle day 8 , the dose of HP-uFSH is adjusted individually according to ovarian response which is monitored using transvaginal ultrasound and serum estradiol. GnRH antagonist (cetrorelix acetate)(Cetrotide®) 0.25 mg S.C once daily is started when the leading follicle is 14 mm in mean diameter and is continued until and including the day of HCG administration .
Interventions
Letrozole (Femara; Novertis pharma AG, Basle, Switzerland) is administered starting on cycle day one for 8 consecutive days . The dose of letrozole is 5mg /day during the first 5 days of cycle and 2.5 mg/day during the subsequent 3 days . Highly purified urinary FSH (HP-uFSH) (Fostimon, IBSA) 300 IU/day is started on cycle day 5 and is continued until and including the day of HCG administration. Starting from cycle day 8 , the dose of HP-uFSH is adjusted individually according to ovarian response which is monitored using transvaginal ultrasound and serum estradiol. GnRH antagonist (cetrorelix acetate)(Cetrotide®) 0.25 mg S.C once daily is started when the leading follicle is 14 mm in mean diameter and is continued until and including the day of HCG administration .
Highly purified urinary FSH (HP-uFSH) (Fostimon, IBSA) 300 IU/day is started on cycle day 5 and is continued until and including the day of HCG administration. Starting from cycle day 8 , the dose of HP-uFSH is adjusted individually according to ovarian response which is monitored using transvaginal ultrasound and serum estradiol. GnRH antagonist (cetrorelix acetate)(Cetrotide®) 0.25 mg S.C once daily is started when the leading follicle is 14 mm in mean diameter and is continued until and including the day of HCG administration .
Eligibility Criteria
You may qualify if:
- Poor responders according to the ESHRE Bologna criteria
You may not qualify if:
- Age \> 42 years FSH\> 12 IU/L Irregular menstrual cycles Unilateral ovary Polycystic ovary syndrome Endometriosis Male factor of infertility requiring ICSI History of recurrent miscarriage Endocrinologic disorders Systemic disease contraindicating pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (2)
Obstetrics &Gynecology Department , Faculty of medicine ,Cairo university
Cairo, Egypt
Riyadh Fertility and Reproductive Health center
Giza, Egypt
Related Publications (1)
Badawy A, Mosbah A, Tharwat A, Eid M. Extended letrozole therapy for ovulation induction in clomiphene-resistant women with polycystic ovary syndrome: a novel protocol. Fertil Steril. 2009 Jul;92(1):236-9. doi: 10.1016/j.fertnstert.2008.04.065. Epub 2008 Aug 15.
PMID: 18706549BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Usama M Fouda, Prof
Cairo University
- STUDY CHAIR
Usama M Fouda, Prof
Riyadh Fertility and Reproductive Health center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.
Study Record Dates
First Submitted
February 12, 2020
First Posted
February 13, 2020
Study Start
April 1, 2018
Primary Completion
March 20, 2020
Study Completion
April 20, 2020
Last Updated
February 13, 2020
Record last verified: 2020-02