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

September 4, 2017 updated by: Reham Elkhateeb, Minia University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Minia, Egypt, 61519
        • Minia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 44 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: aromataze group
patients will receive induction with HMG plus aromataze inhibitor plus GnRh antagonist plus HCG injection
Drug: induction with aromataze inhibitor
letrozole 2.5mg once daily start in the first day of menses for 5days
Other Names:
  • letrozole
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
Other Names:
  • merional
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
Other Names:
  • decapeptyl
Drug: HCG
10.000 IU HCG injection when at least three follicles reach 17mm in diameter
Other Names:
  • choriomon
Active Comparator: classic group
same protocol for induction without aromataze inhibitor
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
Other Names:
  • merional
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
Other Names:
  • decapeptyl
Drug: HCG
10.000 IU HCG injection when at least three follicles reach 17mm in diameter
Other Names:
  • choriomon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
day of HCG injection
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
day of ovum pick up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pregnancy rate
Time Frame: 14 days after ovum pick up
presence of clinical pregnancy
14 days after ovum pick up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 12, 2016

Primary Completion (Actual)

August 24, 2017

Study Completion (Actual)

September 3, 2017

Study Registration Dates

First Submitted

April 12, 2016

First Submitted That Met QC Criteria

April 13, 2016

First Posted (Estimate)

April 18, 2016

Study Record Updates

Last Update Posted (Actual)

September 6, 2017

Last Update Submitted That Met QC Criteria

September 4, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUH 20167
  • MUH20167 (Registry Identifier: Minia University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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