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

Phase 4

Completed

• Conditions: Infertility Indicated for ICSI
• Interventions: Drug: induction with aromataze inhibitor; Drug: HMG; Drug: GnRh a; Drug: HCG

• Registration Number: NCT02741154
• Lead Sponsor: Minia University

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

Study Timeline

• Study First Submitted: 2016-04-12
• Study First Submitted QC: 2016-04-13
• Study First Posted: 2016-04-18
• Study Start: 2016-08-12
• Primary Completion: 2017-08-24
• Status Verified: 2017-09
• Study Completion: 2017-09-03
• Last Update Submitted: 2017-09-04
• Last Update Posted: 2017-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
aromataze group	GnRh a	patients will receive induction with HMG plus aromataze inhibitor plus GnRh antagonist plus HCG injection
aromataze group	induction with aromataze inhibitor	patients will receive induction with HMG plus aromataze inhibitor plus GnRh antagonist plus HCG injection
aromataze group	HMG	patients will receive induction with HMG plus aromataze inhibitor plus GnRh antagonist plus HCG injection
classic group	GnRh a	same protocol for induction without aromataze inhibitor
classic group	HMG	same protocol for induction without aromataze inhibitor
classic group	HCG	same protocol for induction without aromataze inhibitor
aromataze group	HCG	patients will receive induction with HMG plus aromataze inhibitor plus GnRh antagonist plus HCG injection

Primary Outcome Measures

Name	Time	Method
Number of follicles per cycle that reach more than 17mm in diameter(quantity of ova)	day of HCG injection	measurement of the diameter of follicles by transvaginal ultrasoundand description of diameter in report
quality of ova	day of ovum pick up	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

Name	Time	Method
pregnancy rate	14 days after ovum pick up	presence of clinical pregnancy

Trial Locations

Locations (1)

Minia University; 🇪🇬 Minia, Egypt