NCT02703584

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
276

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2016

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 9, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

April 28, 2022

Status Verified

June 1, 2016

Enrollment Period

2.5 years

First QC Date

March 3, 2016

Last Update Submit

April 26, 2022

Conditions

Infertility

Keywords

Double trigger

Outcome Measures

Primary Outcomes (1)

  • Number of mature oocytes

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

    2 days after randomization

Secondary Outcomes (1)

  • Blastocyst rate

    8 days after the randomization

Study Arms (2)

Double trigger

EXPERIMENTAL

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

Drug: BuseralinDrug: pregnyl

control

PLACEBO COMPARATOR

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

Other: PlaceboDrug: pregnyl

Interventions

BuseralinDRUG
Also known as: Suprefact
Double trigger
PlaceboOTHER
Also known as: normal saline
control
pregnylDRUG
Also known as: hCG
Double triggercontrol

Eligibility Criteria

Age18 Years - 41 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TRIO Fertility

Toronto, Ontario, M5G 2K4, Canada

Location

Related Publications (2)

  • Ozelci 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: 38212582DERIVED

  • Haas 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: 32563188DERIVED

MeSH Terms

Conditions

Infertility

Interventions

BuserelinSaline SolutionChorionic Gonadotropin

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteinsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsGonadotropinsPlacental HormonesPregnancy Proteins

Study Officials

  • Robert F Casper, MD

    Scientific Director TRIO IVF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2016

First Posted

March 9, 2016

Study Start

March 1, 2016

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

April 28, 2022

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)