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

Minia University

Status and phase: Completed; Phase 4

Conditions: Infertility Indicated for ICSI

Treatments: Drug: HMG; Drug: HCG; Drug: GnRh a; Drug: induction with aromataze inhibitor

Study type: Interventional

Funder types: Other

Identifiers

NCT02741154

MUH 20167

MUH20167 (Registry Identifier)

Details and patient eligibility

About

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

Full 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

Enrollment: 50 patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

aromataze group

Experimental group

Description:

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

Treatment:

Drug: induction with aromataze inhibitor

Drug: GnRh a

Drug: HCG

Drug: HMG

classic group

Active Comparator group

Description:

same protocol for induction without aromataze inhibitor

Treatment:

Drug: GnRh a

Drug: HCG

Drug: HMG