Role of Aromatase Inhibitor to Enhance Ovulation in Poor Responder During Induction With Short Antagonist Protocol in Cases of ICSI
AIPRICSI
2 other identifiers
interventional
50
1 country
1
Brief Summary
study the effect of aromataze inhibitor induction together with short stimulation protocol by gonadotrphin releasing hormon antagonist in cases that expected to be poor responder before ICSI
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Aug 2016
Shorter than P25 for phase_4
1 active site
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
First Submitted
Initial submission to the registry
April 12, 2016
CompletedFirst Posted
Study publicly available on registry
April 18, 2016
CompletedStudy Start
First participant enrolled
August 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 24, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 3, 2017
CompletedSeptember 6, 2017
September 1, 2017
1 year
April 12, 2016
September 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of follicles per cycle that reach more than 17mm in diameter(quantity of ova)
measurement of the diameter of follicles by transvaginal ultrasoundand description of diameter in report
day of HCG injection
quality of ova
After ova picking up examination of all ova under microscope and report how many ova reach metaphase II (quality) if more than 3 ova reach metaphase II considered satisfactory quality of ova in the current cycle
day of ovum pick up
Secondary Outcomes (1)
pregnancy rate
14 days after ovum pick up
Study Arms (2)
aromataze group
EXPERIMENTALpatients will receive induction with HMG plus aromataze inhibitor plus GnRh antagonist plus HCG injection
classic group
ACTIVE COMPARATORsame protocol for induction without aromataze inhibitor
Interventions
letrozole 2.5mg once daily start in the first day of menses for 5days
HMG 300 IU injection once daily start at first day of menses with follow up by trans vaginal ultrasound (TVUS ) till at least three follicles reach 14 mm in diameter
antagonist given 0.1 ml injection once daily with continous follow up when at least three follicles reach 17mm in diameter HCG 10.000 IU injection and ovum pick up 24-36hours after injection
10.000 IU HCG injection when at least three follicles reach 17mm in diameter
Eligibility Criteria
You may qualify if:
- infertlity indicated for ICSI
- Ovarian factor
- Tubal factor
- Unexplained infertility
- poor responders
You may not qualify if:
- Expected high responder
- Endometriosis
- Male and uterine factors
- Ovarian mass or cyst
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Minia Universitylead
Study Sites (1)
Minia University
Minya, Minya Governorate, 61519, Egypt
Related Publications (1)
Mitwally MF, Casper RF. Aromatase inhibition improves ovarian response to follicle-stimulating hormone in poor responders. Fertil Steril. 2002 Apr;77(4):776-80. doi: 10.1016/s0015-0282(01)03280-0.
PMID: 11937133RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- doctor
Study Record Dates
First Submitted
April 12, 2016
First Posted
April 18, 2016
Study Start
August 12, 2016
Primary Completion
August 24, 2017
Study Completion
September 3, 2017
Last Updated
September 6, 2017
Record last verified: 2017-09