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Prolongation of Progesterone Supplementation in Antagonist Cycles and Pregnancy Outcomes

Primary Purpose

Infertility

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
progesterone
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring progesterone, antagonist, rec FSH, IVF, pregnancy

Eligibility Criteria

18 Years - 39 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Age equal or less than 39
  • Body mass index between 18-29 kg/m2
  • Presence of both ovaries
  • Basal hormonal values on day 2 of the cycle
  • Embryotransfer day3 or day5
  • 1 to 3 cycles

Exclusion Criteria:

  • Endometriosis stage 3
  • Polycystic ovarian syndrome
  • Frozen or testicular sperm

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    stop progesterone

    Arm Description

    Outcomes

    Primary Outcome Measures

    ongoing pregnancy rate

    Secondary Outcome Measures

    Full Information

    First Posted
    June 17, 2010
    Last Updated
    July 1, 2013
    Sponsor
    Universitair Ziekenhuis Brussel
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01147770
    Brief Title
    Prolongation of Progesterone Supplementation in Antagonist Cycles and Pregnancy Outcomes
    Official Title
    The Effect of Progesterone Supplementation During Early Gestations in Patients Treated With Rec FSH/GnRH Antagonist:a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2008 (undefined)
    Primary Completion Date
    January 2010 (Actual)
    Study Completion Date
    June 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universitair Ziekenhuis Brussel

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The objective of this study is to evaluate the effect of the prolongation of luteal support on the ongoing pregnancy rate (beyond 12 weeks of gestation )in recFSH/GnRH antagonist cycles.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infertility
    Keywords
    progesterone, antagonist, rec FSH, IVF, pregnancy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    stop progesterone
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    progesterone
    Other Intervention Name(s)
    utrogestan
    Intervention Description
    duration
    Primary Outcome Measure Information:
    Title
    ongoing pregnancy rate
    Time Frame
    up to 2 years

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    39 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age equal or less than 39 Body mass index between 18-29 kg/m2 Presence of both ovaries Basal hormonal values on day 2 of the cycle Embryotransfer day3 or day5 1 to 3 cycles Exclusion Criteria: Endometriosis stage 3 Polycystic ovarian syndrome Frozen or testicular sperm

    12. IPD Sharing Statement

    Learn more about this trial

    Prolongation of Progesterone Supplementation in Antagonist Cycles and Pregnancy Outcomes

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