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Role of Aromatase Inhibitor to Enhance Ovulation in Poor Responder During Induction With Short Antagonist Protocol in Cases of ICSI (AIPRICSI)

Primary Purpose

Infertility Indicated for ICSI

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
induction with aromataze inhibitor
HMG
GnRh a
HCG
Sponsored by
Minia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility Indicated for ICSI focused on measuring aromataze inhibitor, poor responder ,induction

Eligibility Criteria

18 Years - 44 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • infertlity indicated for ICSI
  • Ovarian factor
  • Tubal factor
  • Unexplained infertility
  • poor responders

Exclusion Criteria:

  • Expected high responder
  • Endometriosis
  • Male and uterine factors
  • Ovarian mass or cyst

Sites / Locations

  • Minia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

aromataze group

classic group

Arm Description

patients will receive induction with HMG plus aromataze inhibitor plus GnRh antagonist plus HCG injection

same protocol for induction without aromataze inhibitor

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

pregnancy rate
presence of clinical pregnancy

Full Information

First Posted
April 12, 2016
Last Updated
September 4, 2017
Sponsor
Minia University
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1. Study Identification

Unique Protocol Identification Number
NCT02741154
Brief Title
Role of Aromatase Inhibitor to Enhance Ovulation in Poor Responder During Induction With Short Antagonist Protocol in Cases of ICSI
Acronym
AIPRICSI
Official Title
Role of Aromatase Inhibitor to Enhance Ovulation in Poor Responder During Induction With Short Antagonist Protocol in Cases of ICSI(Intracytoplasmic Sperm Injection) a Case Control Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
August 12, 2016 (undefined)
Primary Completion Date
August 24, 2017 (Actual)
Study Completion Date
September 3, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
Detailed Description
This is a prospective randomized case control study will be conducted in Maternity hospital IVF unite Minia University after being approved by local ethical committee of obstetrics and gynecology department faculty of medicine, all study details will be explained to patients and informed consent will be obtained before inclusion in the study . enrolled patients will be randomized into two groups using simple randomization by sealed opaque envelops contain serial computer generated numbers Control group will receive HMG 300 IU daily start at first day of menses with follow up by trans vaginal ultrasound (TVUS ) when at least three follicles reach 14mm diameter GnRh antagonist given 0.1 ml continue follow up when at least three follicles reach 17mm in diameter ovum pickup will done under TVUS guide if less than three follicles cycle will be cancelled . Study group will receive same management plus letrozole 2.5mg daily start at the first day of menses for 5 days and continue with same protocol

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility Indicated for ICSI
Keywords
aromataze inhibitor, poor responder ,induction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
aromataze group
Arm Type
Experimental
Arm Description
patients will receive induction with HMG plus aromataze inhibitor plus GnRh antagonist plus HCG injection
Arm Title
classic group
Arm Type
Active Comparator
Arm Description
same protocol for induction without aromataze inhibitor
Intervention Type
Drug
Intervention Name(s)
induction with aromataze inhibitor
Other Intervention Name(s)
letrozole
Intervention Description
letrozole 2.5mg once daily start in the first day of menses for 5days
Intervention Type
Drug
Intervention Name(s)
HMG
Other Intervention Name(s)
merional
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
GnRh a
Other Intervention Name(s)
decapeptyl
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
HCG
Other Intervention Name(s)
choriomon
Intervention Description
10.000 IU HCG injection when at least three follicles reach 17mm in diameter
Primary Outcome Measure Information:
Title
Number of follicles per cycle that reach more than 17mm in diameter(quantity of ova)
Description
measurement of the diameter of follicles by transvaginal ultrasoundand description of diameter in report
Time Frame
day of HCG injection
Title
quality of ova
Description
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
Time Frame
day of ovum pick up
Secondary Outcome Measure Information:
Title
pregnancy rate
Description
presence of clinical pregnancy
Time Frame
14 days after ovum pick up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: infertlity indicated for ICSI Ovarian factor Tubal factor Unexplained infertility poor responders Exclusion Criteria: Expected high responder Endometriosis Male and uterine factors Ovarian mass or cyst
Facility Information:
Facility Name
Minia University
City
Minia
ZIP/Postal Code
61519
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
11937133
Citation
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.
Results Reference
result

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Role of Aromatase Inhibitor to Enhance Ovulation in Poor Responder During Induction With Short Antagonist Protocol in Cases of ICSI

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