NCT01191710

Brief Summary

The aim is to explore whether the incidence of progesterone rise in the late follicular phase differs between GnRH-agonist and GnRH-antagonist protocols for IVF and whether this has an impact on the probability of pregnancy achievement.

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_4

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_4

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

January 1, 2007

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

August 27, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 31, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

September 15, 2010

Status Verified

January 1, 2009

Enrollment Period

4 years

First QC Date

August 27, 2010

Last Update Submit

September 14, 2010

Conditions

Keywords

progesterone

Outcome Measures

Primary Outcomes (1)

  • Incidence of late progesterone rise on the day of HCG triggering

    Up to delivery (2010)

Secondary Outcomes (1)

  • Clinical pregnancy rate Delivery rate

    Up to delivery (2010)

Study Arms (2)

Antagonist group

EXPERIMENTAL

Antagonist protocol for IVF

Other: In vitro fertilization

Agonist group

ACTIVE COMPARATOR

Long Agonist protocol for IVF

Other: In vitro fertilization

Interventions

In vitro fertilization procedure with gonadotropin induced follicular ovarian stimulation

Also known as: IVF, pregnancy, embryo-transfer, progesterone
Agonist groupAntagonist group

Eligibility Criteria

Age21 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age \< 39
  • follicle-stimulating hormone (FSH) \< 12
  • gonadotropin dose 100-300IU

You may not qualify if:

  • endometriosis
  • known endocrine disorder
  • blood analyzed in another laboratory

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biogenesis

Thessaloniki, Pylaia, 55536, Greece

Location

Related Publications (2)

  • Papanikolaou EG, Kolibianakis EM, Pozzobon C, Tank P, Tournaye H, Bourgain C, Van Steirteghem A, Devroey P. Progesterone rise on the day of human chorionic gonadotropin administration impairs pregnancy outcome in day 3 single-embryo transfer, while has no effect on day 5 single blastocyst transfer. Fertil Steril. 2009 Mar;91(3):949-52. doi: 10.1016/j.fertnstert.2006.12.064. Epub 2007 Jun 6.

    PMID: 17555751BACKGROUND
  • Papanikolaou EG, Pados G, Grimbizis G, Bili E, Kyriazi L, Polyzos NP, Humaidan P, Tournaye H, Tarlatzis B. GnRH-agonist versus GnRH-antagonist IVF cycles: is the reproductive outcome affected by the incidence of progesterone elevation on the day of HCG triggering? A randomized prospective study. Hum Reprod. 2012 Jun;27(6):1822-8. doi: 10.1093/humrep/des066. Epub 2012 Mar 14.

Related Links

MeSH Terms

Interventions

Fertilization in VitroPregnancyEmbryo TransferProgesterone

Intervention Hierarchy (Ancestors)

Reproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative TechniquesReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological PhenomenaPregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCorpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsProgesterone CongenersGonadal Steroid Hormones

Study Officials

  • Basil Tarlatzis, MD

    BioGenesis

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 27, 2010

First Posted

August 31, 2010

Study Start

January 1, 2007

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

September 15, 2010

Record last verified: 2009-01

Locations