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Trial · Interventional

Status unknownPhase 4Registry data

Comparison Between Recombinant Versus Urinary hCG for Ovulation Induction in High Responders

NCTNCT00415766 (opens ClinicalTrials.gov in a new tab)Other idovitrelle vs pregnyl
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
150 participants (actual)
Sponsor
Eugonia · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Greece

Start
Jun 2013
Primary completion
Dec 2015
Completion
Jul 2016 (estimated)
First posted
25 Dec 2006 (estimated)
Last update posted
20 Jan 2016 (estimated)
Conditions
Infertility

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20132014201520162017
  1. Ph 4

    Comparison Between Recombinant Versus Urinary hCG for Ovulation Induction in High Responders

    NCT00415766

    Jun 2013 to est. Jul 2016

Registry summary

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

The purpose of this study is to compare the clinical outcomes of recombinant human chorionic gonadotrophin (rHCG) and urinary HCG (uHCG) in patients undergoing IVF cycles.

Interventions

  • rHCG 250ugDrug
  • uHCG 5000 IUDrug
  • uHCG 7500 IUDrug

Arms3

  • Active comparator

    rHCG 250 ug

    Injection of 250 ug Ovitrelle to trigger final oocyte maturation

  • Active comparator

    uHCG 5000 IU

    Injection of 5000 IU Pregnyl to trigger final oocyte maturation

  • Active comparator

    uHCG 7500 IU

    Injection of 7500 IU Pregnyl to trigger final oocyte maturation

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percentage of mature oocytes

    Time frame · Day of oocyte retrieval (Day 0)

    Registry description

    Percentage MII/COCs

Secondary outcomes(8)

  1. Positive test per embryo transfer

    Time frame · 15 days post oocyte retrieval

  2. Clinical pregnancy per embryo transfer

    Time frame · 7 weeks of gestation

  3. Ongoing pregnancy per embryo transfer

    Time frame · 12 weeks of gestation

  4. Level of serum hCG on day of oocyte retrieval

    Time frame · Day of oocyte retrieval

  5. Number of oocytes (COC) retrieved

    Time frame · Day of oocyte retrieval

  6. Number of mature oocytes (MII)

    Time frame · Day of oocyte retrieval

  7. Oocyte retrieval rate

    Time frame · Day of oocyte retrieval (Day 0)

    Registry description

    Number of oocytes retrieved/number of follicles on the day of triggering final oocyte maturation

  8. Incidence of severe early OHSS

    Time frame · up to Day 5 post oocyte retrieval

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.

A trial that is still running, or that stopped early, may post results later.

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 18 Years up to 39 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * At least 14 follicles \>11mm on the day of triggering final oocyte maturation * Pretreated with GnRH antagonist protocol Exclusion Criteria: * Poor responders * Women with 25 or more follicles on the day of trigger

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