Progesterone Rise in Agonist Versus Antagonist in Vitro Fertilization (IVF) Cycles

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Universitair Ziekenhuis Brussel.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
BioGenesis
Information provided by:
Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
NCT01191710
First received: August 27, 2010
Last updated: September 14, 2010
Last verified: January 2009
  Purpose

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.


Condition Intervention Phase
Pregnancy Outcome After In Vitro Fertilization (IVF)
Other: In vitro fertilization
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Is the Clinical Outcome Affected by the Incidence of Progesterone Elevation on the Day of hCG Triggering When Agonist Protocol is Compared to Antagonist Protocol for IVF

Resource links provided by NLM:


Further study details as provided by Universitair Ziekenhuis Brussel:

Primary Outcome Measures:
  • Incidence of late progesterone rise on the day of HCG triggering [ Time Frame: Up to delivery (2010) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical pregnancy rate Delivery rate [ Time Frame: Up to delivery (2010) ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: January 2007
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Antagonist group
Antagonist protocol for IVF
Other: In vitro fertilization
In vitro fertilization procedure with gonadotropin induced follicular ovarian stimulation
Other Names:
  • IVF
  • pregnancy
  • embryo-transfer
  • progesterone
Active Comparator: Agonist group
Long Agonist protocol for IVF
Other: In vitro fertilization
In vitro fertilization procedure with gonadotropin induced follicular ovarian stimulation
Other Names:
  • IVF
  • pregnancy
  • embryo-transfer
  • progesterone

Detailed Description:

In view of the current debate concerning possible differences in efficacy between the two GnRH analogues, the current study aimed to explore whether progesterone control in the late follicular phase differs when GnRH-agonist is used as compared to GnRH-antagonist and if so to what extend does the progesterone rise have an impact on the probability of achieving a pregnancy.

  Eligibility

Ages Eligible for Study:   21 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • endometriosis
  • known endocrine disorder
  • blood analyzed in another laboratory
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01191710

Locations
Greece
Biogenesis
Thessaloniki, Pylaia, Greece, 55536
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
BioGenesis
Investigators
Study Chair: Basil Tarlatzis, MD BioGenesis
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Papanikolaou Evangelos, Human Reproduction and Genetics Foundation (HRG)
ClinicalTrials.gov Identifier: NCT01191710     History of Changes
Other Study ID Numbers: ProgRise001
Study First Received: August 27, 2010
Last Updated: September 14, 2010
Health Authority: Greece: Ethics Committee

Keywords provided by Universitair Ziekenhuis Brussel:
progesterone

Additional relevant MeSH terms:
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014