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Trial · Interventional

CompletedPhase 4Registry data

Co Administration of GnRH Agonist and hCG for Final Oocyte Maturation

NCTNCT02703584 (opens ClinicalTrials.gov in a new tab)Other id03012016
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
276 participants (actual)
Sponsor
Mount Sinai Hospital, Canada · Other
Design
Randomized · Quadruple masking
Countries
1 country

Canada

Start
Mar 2016
Primary completion
Sept 2018
Completion
Sept 2018
First posted
9 Mar 2016 (estimated)
Last update posted
28 Apr 2022
Conditions
Infertility

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2016201720182019
  1. Ph 4

    Co Administration of GnRH Agonist and hCG for Final Oocyte Maturation

    NCT02703584

    Mar 2016 to Sept 2018

Registry summary

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

All the studies, demonstrating improved oocyte maturity and high pregnancy rate with the dual trigger are all retrospective. The investigators therefore aim to perform a prospective randomized controlled study in normal responders, comparing cycles triggered with hCG to those triggered with hCG+GnRH agonist.

Interventions

  • BuseralinDrug
  • PlaceboOther
  • pregnylDrug

Arms2

  • Experimental

    Double trigger

    Triggering of ovulation with GnRH agonist ( Suprefact 0.5mg) + hCG ( Pregnyl 10,000IU)

  • Placebo comparator

    control

    Triggering of ovulation with hCH ( Pregnyl 10,000IU) + Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of mature oocytes

    Time frame · 2 days after randomization

    Registry description

    We will gather the information regarding the number of mature oocytes 2 days after the triggering- ( randomization)

Secondary outcomes(1)

  1. Blastocyst rate

    Time frame · 8 days after the randomization

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.

  • DerivedOzelci R, Yenigul NN, Dilbaz S, Dilbaz B, Aldemir O, Kaplanoglu I, Gucel F, Baser E, Tekin OM. The Association of ICSI Outcomes with Semen and Blood Bisphenol A Concentrations of the Male Partner. Reprod Sci. 2024 May;31(5):1323-1331. doi: 10.1007/s43032-023-01446-y. Epub 2024 Jan 11. PMID 38212582
  • DerivedHaas J, Bassil R, Samara N, Zilberberg E, Mehta C, Orvieto R, Casper RF. GnRH agonist and hCG (dual trigger) versus hCG trigger for final follicular maturation: a double-blinded, randomized controlled study. Hum Reprod. 2020 Jul 1;35(7):1648-1654. doi: 10.1093/humrep/deaa107. PMID 32563188

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 41 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Women during one of their first 3 IVF cycle attempts * Women between the ages of 18-42. * BMI (body mass index) of 18-35. * AMH (Anti mullerian hormone) \> 1 ng/ml * FSH˂ 20 IU/L. * Informed consent. Exclusion Criteria: * Women with low ovarian response * Previous enrollment in this study. * AFC\>20 * E2 above 15,000 pmol/l at the trigger day. * hypersensitive to Suprefact/Pregny/gonal F/Purigon/Menopur/progesterone, and/or their ingredients/components of the formulation * primary ovarian failure * pregnancy and breast-feeding * active blood clots * undiagnosed uterine or genital bleeding * endometriosis * uncontrolled hypertension; * uncontrolled diabetes * abnormal liver and kidney functions * abnormal ECG, e.g. QT prolongation and torsades de pointes * cancers/tumors, e.g. pituitary adenomas, ovarian cysts, etc. * HIV, HBV and HCV infections * low bone mineral density (BMD) and an increased risk of bone fracture, such as chronic alcohol and/or tobacco use, presumed or strong family history of osteoporosis or chronic use of drugs that can reduce bone mass such as anticonvulsants or corticosteroids * suicidal tendency, history or disposition to seizures, state of confusion, clinically relevant psychiatric disorders, and brain lesions * Use of an investigational drug or participation in an investigational study within 30 days prior to this study.

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