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

September 14, 2010 updated by: Universitair Ziekenhuis Brussel

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Actual)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Pylaia
      • Thessaloniki, Pylaia, Greece, 55536
        • Biogenesis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • pregnancy
  • progesterone
  • IVF
  • embryo-transfer
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:
  • pregnancy
  • progesterone
  • IVF
  • embryo-transfer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of late progesterone rise on the day of HCG triggering
Time Frame: Up to delivery (2010)
Up to delivery (2010)

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical pregnancy rate Delivery rate
Time Frame: Up to delivery (2010)
Up to delivery (2010)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitair Ziekenhuis Brussel

Collaborators

BioGenesis

Investigators

  • Study Chair: Basil Tarlatzis, MD, Biogenesis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Anticipated)

January 1, 2011

Study Completion (Anticipated)

January 1, 2011

Study Registration Dates

First Submitted

August 27, 2010

First Submitted That Met QC Criteria

August 30, 2010

First Posted (Estimate)

August 31, 2010

Study Record Updates

Last Update Posted (Estimate)

September 15, 2010

Last Update Submitted That Met QC Criteria

September 14, 2010

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ProgRise001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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