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Trial · Interventional

CompletedPhase 4Registry data

The Use of GnRH Agonist Trigger for Final Follicle Maturation in Women Undergoing Assisted Reproductive Technologies

Overview

Status
Completed
Phase
Phase 4
Enrollment
277 participants (actual)
Sponsor
American University of Beirut Medical Center · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Lebanon

Start
1 Mar 2017
Primary completion
1 Jul 2021
Completion
1 Oct 2021
First posted
30 May 2017
Last update posted
20 Jul 2023
Conditions
Sterility · Infertility

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201720182019202020212022
  1. Ph 4

    The Use of GnRH Agonist Trigger for Final Follicle Maturation in Women Undergoing Assisted Reproductive Technologies

    NCT03169166

    1 Mar 2017 to 1 Oct 2021

Registry summary

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

This is a prospective comparative randomized controlled trial investigating the effect of two GnRH agonist trigger protocols on the ongoing pregnancy rate in hyper-responder women undergoing assisted reproductive technology.

Interventions

  • TriptorelinDrug

Arms2

  • Experimental

    Repeated 3-dose GnRHa " Triptorelin"

    Triptorelin pre-filled syringes (Gonapeptyl 0.1mg; Ferring GmbH, Germany) will be administered subcutaneously in three repeated doses 12 hours apart (0.3/0.2/0.2mg) when at least three follicles 18 mm in diameter have been observed by ultrasound examination.

  • No intervention

    Conventional 1-dose GnRHa " Triptorelin"

    Triptorelin pre-filled syringes will be administered subcutaneously in a single dose (0.3 mg) when at least three follicles 18 mm in diameter have been observed by ultrasound examination.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Ongoing pregnancy rate in hyper-responder women undergoing assisted reproductive technology cycles

    Time frame · 20 weeks from Last Menstrual Period (LMP)

Secondary outcomes(1)
  1. Oocyte collection rate

    Time frame · On the day of ovum pick-up

    Registry description

    oocyte maturation rate ovarian volume on the day of hCG titer

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 18 Years up to 40 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Normal uterine cavity (as assessed by hysteroscopy or HSG). * Normal hormonal investigation: TSH, PRL. * More than 15 follicles (≥12 mm in diameter) on ultrasound, and/or estradiol level of \> 3500 pg/ml on the day of trigger. Exclusion Criteria: * History of three or more miscarriages. * History of three or more previous IVF failures. * Abnormal uterine cavity (Hysteroscopy or HSG).

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