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

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ClinicalTrials.gov Identifier: NCT01191710
Recruitment Status : Unknown
Verified January 2009 by Universitair Ziekenhuis Brussel.
Recruitment status was:  Active, not recruiting
First Posted : August 31, 2010
Last Update Posted : September 15, 2010
Sponsor:
Collaborator:
BioGenesis
Information provided by:
Universitair Ziekenhuis Brussel

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.

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

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2007
Estimated Primary Completion Date : January 2011
Estimated Study Completion Date : January 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Incidence of late progesterone rise on the day of HCG triggering [ Time Frame: Up to delivery (2010) ]

Secondary Outcome Measures :
  1. Clinical pregnancy rate Delivery rate [ Time Frame: Up to delivery (2010) ]


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Ages Eligible for Study:   21 Years to 39 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01191710


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

Additional Information:
Publications:
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
First Posted: August 31, 2010    Key Record Dates
Last Update Posted: September 15, 2010
Last Verified: January 2009

Keywords provided by Universitair Ziekenhuis Brussel:
progesterone

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