NCT02741154

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Minia University · Academic / Other
• Sex: Female
• Age: 18 Years – 44 Years
• Healthy volunteers: Not accepted

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

Conditions

• Infertility Indicated for ICSI

Interventions

Type	Name	Description
DRUG	induction with aromataze inhibitor	letrozole 2.5mg once daily start in the first day of menses for 5days
DRUG	HMG	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
DRUG	GnRh a	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
DRUG	HCG	10.000 IU HCG injection when at least three follicles reach 17mm in diameter

Timeline

• Start date: 2016-08-12
• Primary completion: 2017-08-24
• Completion: 2017-09-03
• First posted: 2016-04-18
• Last updated: 2017-09-06

Locations

1 site across 1 country: Egypt