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Trial · Interventional

CompletedPhase 4Registry data

Three Small Doses of HCG Versus Booster Dose of HCG on Ovum Pickup Day

Overview

Status
Completed
Phase
Phase 4
Enrollment
200 participants (actual)
Sponsor
Cairo University · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Egypt

Start
Mar 2015
Primary completion
Jan 2018
Completion
Jan 2018
First posted
25 Mar 2015 (estimated)
Last update posted
29 Jan 2018
Conditions
Infertility

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20152016201720182019
  1. Ph 4

    Three Small Doses of HCG Versus Booster Dose of HCG on Ovum Pickup Day

    NCT02397551

    Mar 2015 to Jan 2018

Registry summary

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

To salvage the luteal phase and improve pregnancy rate in antagonist IVF/ICSI cycles triggered with GnRH agonist. Two strategies are compared supplementing the luteal phase with three small doses (500 IU) of HCG and giving a booster dose of HCG (1500 IU) on the day of ovum pickup.

Interventions

  • IVF/ICSIProcedure
  • Human Chorionic GonadotropinDrug

Arms2

  • Active comparator

    Small doses of HCG

    Supplementing the luteal phase with three small doses (500 IU) of HCG after trigger with GnRH agonist in antagonist IVF/ICSI cycles in high responders

  • Active comparator

    Booster HCG dose

    Booster HCG dose GnRH agonist only to trigger final maturation followed by a booster dose of 1500 IU of HCG on the day of ovum pickup

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Clinical pregnancy rate

    Time frame · 1 year

    Registry description

    The number of cycles with a positive pregnancy test and evidence of a gestational sac with fetal pulsations after 5weeks from pregnancy test

Secondary outcomes(1)
  1. OHSS rate

    Time frame · 1 year

    Registry description

    The number of cycles with evidence of OHSS

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.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 20 Years up to 37 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * High responder females undergoing antagonist protocol IVF/ICSI cycle * More than 14 MII oocytes * Estradiol more than 3500 pg/ml on day of trigger Exclusion Criteria: * Any other protocol * Normal or poor responders

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