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Completed

NCT Number: NCT02741154

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

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

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Key information

Conditions

Infertility Indicated for ICSI

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Minia University

Minya, Minya Governorate, 61519, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

induction with aromataze inhibitor

Drug

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

Other names: letrozole

hMG

Drug

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

Other names: merional

GnRh a

Drug

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

Other names: decapeptyl

HCG

Drug

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

Other names: choriomon

Primary outcomes

  1. Number of follicles per cycle that reach more than 17mm in diameter(quantity of ova)

    Time frame: day of HCG injection

    measurement of the diameter of follicles by transvaginal ultrasoundand description of diameter in report

  2. quality of ova

    Time frame: 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 outcomes

  1. pregnancy rate

    Time frame: 14 days after ovum pick up

    presence of clinical pregnancy

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

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

Acronym: AIPRICSI

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 18, 2016
Registry last updated
Sep 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.