NCT02173977

Brief Summary

The purpose of this study is to evaluate the appropriate controlled ovarian hyperstimulation (COH) protocol in good prognosis patients undergoing IVF treatment. The stimulation characteristics of cycles which include ultrashort flare GnRH agonist combined with flexible multidose GnRH antagonist will be compared to the flexible multidose GnRH antagonist protocol. The investigators hypothesized that combining the stimulatory effect of GnRH agonists and immediate suppression of the GnRH antagonist in a unique protocol may be a valuable new COH strategy for IVF patients, resulting in improved ART outcome.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2014

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2014

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2014

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 25, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

June 25, 2014

Status Verified

June 1, 2014

Enrollment Period

1.9 years

First QC Date

June 2, 2014

Last Update Submit

June 23, 2014

Conditions

Infertility

Keywords

GnRH AgonistGnRH AntagonistOHSS

Outcome Measures

Primary Outcomes (1)

  • Ongoing pregnancy rates

    2 years

Secondary Outcomes (9)

  • Total gonadotropin use

    2 Years

  • Biochemical pregnancy

    2 Years

  • Clinical pregnancy

    2 Years

  • Multiple pregnancy rate

    2 Years

  • Miscarriage rate

    2 Years

  • +4 more secondary outcomes

Other Outcomes (1)

  • Positive Pregnancy Test

    2 Years

Study Arms (2)

ARM A- Agonist/Antagonist protocol

ACTIVE COMPARATOR

The Ultrashort GnRH Agonist/antagonist method entails pre-treatment with oral contraceptive pills before the combination of GnRH ultrashort agonist and antagonist protocol

Other: ARM A- Agonist/Antagonist protocolOther: ARM B- Antagonist protocol

ARM B- Antagonist protocol

ACTIVE COMPARATOR

The standard IVF method entails Flexible Multidose GnRH Antagonist protocol during COH

Other: ARM A- Agonist/Antagonist protocolOther: ARM B- Antagonist protocol

Interventions

ARM A- Agonist/Antagonist protocolOTHER

In vitro fertilization (IVF/ICSI)

ARM A- Agonist/Antagonist protocolARM B- Antagonist protocol
ARM B- Antagonist protocolOTHER

In vitro fertilization (IVF/ICSI)

ARM A- Agonist/Antagonist protocolARM B- Antagonist protocol

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Up to three previous IVF attempts

You may not qualify if:

  • Patients with poor or no response in previous COH for IVF cycles
  • Abnormal ovarian reserve test i.e. anti-mullerian hormone (AMH), Antral follicle test
  • Risk factor for Diminished Ovarian Reserve

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center- IVF unit

Ramat Gan, Israel, 52621, Israel

Location

Related Publications (5)

  • Orvieto R, Nahum R, Rabinson J, Gemer O, Anteby EY, Meltcer S. Ultrashort flare GnRH agonist combined with flexible multidose GnRH antagonist for patients with repeated IVF failures and poor embryo quality. Fertil Steril. 2009 Apr;91(4 Suppl):1398-400. doi: 10.1016/j.fertnstert.2008.04.064. Epub 2008 Aug 3.

    PMID: 18675974BACKGROUND

  • Orvieto R. The ultrashort flare GnRH-agonist/GnRH-antagonist protocol enables cycle programming and may overcome the "detrimental effect" of the oral contraceptive. Fertil Steril. 2012 Sep;98(3):e17-8; author reply e19. doi: 10.1016/j.fertnstert.2012.06.053. Epub 2012 Jul 26. No abstract available.

    PMID: 22840381BACKGROUND

  • Orvieto R, Nahum R, Zohav E, Liberty G, Anteby EY, Meltcer S. GnRH-agonist ovulation trigger in patients undergoing controlled ovarian hyperstimulation for IVF with ultrashort flare GnRH-agonist combined with multidose GnRH-antagonist protocol. Gynecol Endocrinol. 2013 Jan;29(1):51-3. doi: 10.3109/09513590.2012.705376. Epub 2012 Aug 3.

    PMID: 22857268BACKGROUND

  • Orvieto R, Meltcer S, Liberty G, Rabinson J, Anteby EY, Nahum R. A combined approach to patients with repeated IVF failures. Fertil Steril. 2010 Nov;94(6):2462-4. doi: 10.1016/j.fertnstert.2010.03.057. Epub 2010 May 7.

    PMID: 20451192BACKGROUND

  • Orvieto R, Kruchkovich J, Rabinson J, Zohav E, Anteby EY, Meltcer S. Ultrashort gonadotropin-releasing hormone agonist combined with flexible multidose gonadotropin-releasing hormone antagonist for poor responders in in vitro fertilization/embryo transfer programs. Fertil Steril. 2008 Jul;90(1):228-30. doi: 10.1016/j.fertnstert.2007.06.022. Epub 2007 Aug 6.

    PMID: 17681292BACKGROUND

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Raoul Orvieto, MD

    Infertility & IVF Unit, Dept. Obstetrics & Gynecology - Director

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2014

First Posted

June 25, 2014

Study Start

June 1, 2014

Primary Completion

May 1, 2016

Study Completion

May 1, 2017

Last Updated

June 25, 2014

Record last verified: 2014-06

Locations

IL(1)