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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Infertility Indicated for ICSI

Intervention / Treatment
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* Drug: induction with aromataze inhibitor
* Drug: HMG
* Drug: GnRh a
* Drug: HCG


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: aromataze group<br>patients will receive induction with HMG plus aromataze inhibitor plus GnRh antagonist plus HCG injection | Drug: induction with aromataze inhibitor<br>* letrozole 2.5mg once daily start in the first day of menses for 5days<br>* Other names: letrozole;Drug: HMG<br>* 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<br>* Other names: merional;Drug: GnRh a<br>* 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<br>* Other names: decapeptyl;Drug: HCG<br>* 10.000 IU HCG injection when at least three follicles reach 17mm in diameter<br>* Other names: choriomon;|
| Active Comparator: classic group<br>same protocol for induction without aromataze inhibitor | Drug: HMG<br>* 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<br>* Other names: merional;Drug: GnRh a<br>* 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<br>* Other names: decapeptyl;Drug: HCG<br>* 10.000 IU HCG injection when at least three follicles reach 17mm in diameter<br>* Other names: choriomon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy rate | presence of clinical pregnancy | 14 days after ovum pick up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aromataze inhibitor, poor responder ,induction