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Luteal Support and Intrauterine Insemination (IUI) With Clomiphene Citrate

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
micronized 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 IUI, clomiphene citrate, utrogestan

Eligibility Criteria

18 Years - 36 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Age ≤ 36 years
  • Body mass index between 18 and 29
  • Presence of both ovaries
  • Basal levels of estradiol (≤ 80 pg/ml) and progesterone (≤ 1.6ng/ml) on day one of the cycle and a day three FSH level of <12IU/L
  • Patients can enter the study only once.
  • Only the first IUI attempt will be included ( at the 2nd and 3 rd attempt progesterone could be administrated if it is necessary but these attempts will be excluded from the study)
  • Normal HSG (maximum 3 months prior starting the stimulation).
  • Donor sperm can be included

Exclusion Criteria:

  • Polycystic ovarian syndrome (Rotterdam criteria)
  • Endometriosis(≥AFS III)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    micronized progesterone

    no utrogestan

    Arm Description

    Outcomes

    Primary Outcome Measures

    ongoing pregnancy rate

    Secondary Outcome Measures

    implantation rate,clinical pregnancy rate

    Full Information

    First Posted
    January 11, 2010
    Last Updated
    July 1, 2013
    Sponsor
    Universitair Ziekenhuis Brussel
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01046708
    Brief Title
    Luteal Support and Intrauterine Insemination (IUI) With Clomiphene Citrate
    Official Title
    Ovulation Induction With Clomiphene Citrate: to Support or Not to Support the Luteal Phase
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2008 (undefined)
    Primary Completion Date
    August 2009 (Actual)
    Study Completion Date
    July 2012 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to assess the effect of luteal phase supplement (LPS) on pregnancy rate in IUI cycles stimulated with clomiphene citrate.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infertility
    Keywords
    IUI, clomiphene citrate, utrogestan

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    300 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    micronized progesterone
    Arm Type
    Experimental
    Arm Title
    no utrogestan
    Arm Type
    No Intervention
    Intervention Type
    Drug
    Intervention Name(s)
    micronized progesterone
    Other Intervention Name(s)
    utrogestan
    Intervention Description
    600mg in 3 separate doses per day
    Primary Outcome Measure Information:
    Title
    ongoing pregnancy rate
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    implantation rate,clinical pregnancy rate
    Time Frame
    1 year

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    36 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age ≤ 36 years Body mass index between 18 and 29 Presence of both ovaries Basal levels of estradiol (≤ 80 pg/ml) and progesterone (≤ 1.6ng/ml) on day one of the cycle and a day three FSH level of <12IU/L Patients can enter the study only once. Only the first IUI attempt will be included ( at the 2nd and 3 rd attempt progesterone could be administrated if it is necessary but these attempts will be excluded from the study) Normal HSG (maximum 3 months prior starting the stimulation). Donor sperm can be included Exclusion Criteria: Polycystic ovarian syndrome (Rotterdam criteria) Endometriosis(≥AFS III)

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20719809
    Citation
    Kyrou D, Fatemi HM, Tournaye H, Devroey P. Luteal phase support in normo-ovulatory women stimulated with clomiphene citrate for intrauterine insemination: need or habit? Hum Reprod. 2010 Oct;25(10):2501-6. doi: 10.1093/humrep/deq223. Epub 2010 Aug 18.
    Results Reference
    derived

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    Luteal Support and Intrauterine Insemination (IUI) With Clomiphene Citrate

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