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Trial · Interventional

CompletedPhase 4Registry data

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

Short name AIPRICSI

NCTNCT02741154 (opens ClinicalTrials.gov in a new tab)Other idMUH 20167Other idMUH20167
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
50 participants (actual)
Sponsor
Minia University · Other
Design
Randomized · Single masking
Countries
1 country

Egypt

Start
12 Aug 2016
Primary completion
24 Aug 2017
Completion
3 Sept 2017
First posted
18 Apr 2016 (estimated)
Last update posted
6 Sept 2017
Conditions
Infertility Indicated for ICSI

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201620172018
  1. Ph 4

    AIPRICSI

    NCT02741154

    12 Aug 2016 to 3 Sept 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • induction with aromataze inhibitorDrug
  • HMGDrug
  • GnRh aDrug
  • HCGDrug

Arms2

  • Experimental

    aromataze group

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

  • Active comparator

    classic group

    same protocol for induction without aromataze inhibitor

Primary outcomes2

Outcomes the sponsor listed as primary.

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

    Time frame · day of HCG injection

    Registry description

    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

    Registry description

    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)

  1. pregnancy rate

    Time frame · 14 days after ovum pick up

    Registry description

    presence of clinical pregnancy

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultMitwally MF, Casper RF. Aromatase inhibition improves ovarian response to follicle-stimulating hormone in poor responders. Fertil Steril. 2002 Apr;77(4):776-80. doi: 10.1016/s0015-0282(01)03280-0. PMID 11937133

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 44 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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