Extended Letrozole Regimen Versus Clomiphene Citrate for Superovulation in Patients With Unexplained Infertility Undergoing Intrauterine Insemination
1 other identifier
interventional
214
1 country
2
Brief Summary
The aim of this randomized controlled trial is to compare the efficacy of extended letrozole regimen (2.5mg/day from cycle day 1 to 9) with clomiphene citrate (100 mg/day from cycle day 3 to 7) in women with unexplained infertility undergoing superovulation and intrauterine insemination .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2008
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
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedFirst Posted
Study publicly available on registry
November 2, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedJuly 12, 2011
July 1, 2011
2.2 years
November 1, 2010
July 11, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical pregnancy rate
Presence of intrauterine gestational sac detected by transvaginal ultrasound
5 weeks after intrauterine insemination
Secondary Outcomes (1)
Ongoing Pregnancy Rate
18 weeks after intrauterine insemination
Study Arms (2)
Extended letrozole regimen
EXPERIMENTALClomiphene citrate regimen
ACTIVE COMPARATORInterventions
Letrozole (Femara; Novartis pharma AG, Basle, Switzerland) 2.5mg /day is administered from cycle day 1 to 9 . Human chorionic gonadotropin (Pregnyl; N.V. Organon, Oss, Holland) ( 10.000 IU/I.M ) is administered to trigger ovulation when at least one follicle measures more than 18mm in mean diameter .Intrauterine insemination is performed 36 - 40 hours after HCG injection . Starting from cycle day 9 , ultrasound scans are repeated daily to monitor follicle growth . Serum estradiol and endometrial thickness are measured on the day of HCG administration. Serum B-subunit HCG is measured 2 weeks after IUI to diagnose pregnancy .
Clomiphene citrate(Clomid; Aventis pharma S.AE, Global Napi pharmaceuticals, Cairo, Egypt) 100 mg/day is administered from cycle day 3 to 7. Human chorionic gonadotropin (Pregnyl; N.V. Organon, Oss, Holland) ( 10.000 IU/I.M ) is administered to trigger ovulation when at least one follicle measures more than 18mm in mean diameter .Intrauterine insemination is performed 36 - 40 hours after HCG injection . Starting from cycle day 9 , ultrasound scans are repeated daily to monitor follicle growth . Serum estradiol and endometrial thickness are measured on the day of HCG administration. Serum B-subunit HCG is measured 2 weeks after IUI to diagnose pregnancy .
Eligibility Criteria
You may qualify if:
- Patients with unexplained infertility
- Age between 18 - 37 years
- Period of infertility \> 1 year
- Patent Fallopian tubes detected by hysterosalpingography and/or laparoscopy
- Normal basal luteinizing hormone (LH), follicle stimulating hormone (FSH) and prolactin concentrations
- Normal recent semen analysis (according to World Health Organization criteria)
You may not qualify if:
- FSH\> 10 IU/L
- Irregular menstrual cycles
- Polycystic ovary syndrome
- Endometriosis
- Endocrinologic disorders
- Systemic disease contraindicating pregnancy
- Previous IUI cycles
- liver or kidney diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
- Ahmed Elgazzar Hospitalcollaborator
Study Sites (2)
Ahmed Elgazzar hospital
Cairo, Egypt
Cairo university hospital
Cairo, Egypt
Related Publications (3)
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: 18706549BACKGROUNDBadawy A, Elnashar A, Totongy M. RETRACTED: Clomiphene citrate or aromatase inhibitors for superovulation in women with unexplained infertility undergoing intrauterine insemination: a prospective randomized trial. Fertil Steril. 2009 Oct;92(4):1355-1359. doi: 10.1016/j.fertnstert.2008.06.013. Epub 2008 Aug 9.
PMID: 18692823BACKGROUNDFouda UM, Sayed AM. Extended letrozole regimen versus clomiphene citrate for superovulation in patients with unexplained infertility undergoing intrauterine insemination: a randomized controlled trial. Reprod Biol Endocrinol. 2011 Jun 21;9:84. doi: 10.1186/1477-7827-9-84.
PMID: 21693030DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Usama M Fouda, M.D, PhD
Cairo University
- STUDY DIRECTOR
Ahmed M Sayed, M.D, PhD
Cairo University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 1, 2010
First Posted
November 2, 2010
Study Start
September 1, 2008
Primary Completion
November 1, 2010
Study Completion
December 1, 2010
Last Updated
July 12, 2011
Record last verified: 2011-07