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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02741154

Acronym

AIPRICSI

Enrollment

Registered

2016-04-18

Start date

2016-08-12

Completion date

2017-09-03

Last updated

2017-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility Indicated for ICSI

Keywords

aromataze inhibitor, poor responder ,induction

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

Interventions

DRUGinduction with aromataze inhibitor

letrozole 2.5mg once daily start in the first day of menses for 5days

DRUGHMG

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

DRUGGnRh 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

DRUGHCG

10.000 IU HCG injection when at least three follicles reach 17mm in diameter

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 44 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
pregnancy rate	14 days after ovum pick up	presence of clinical pregnancy

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026