Oral Estradiol Valerate Versus Oral Contraceptive Pill in Invitro Fertilization Patients

This study is currently recruiting participants.
Verified December 2011 by Instituto Valenciano de Infertilidad, Spain
Sponsor:
Information provided by (Responsible Party):
Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier:
NCT01501448
First received: December 27, 2011
Last updated: December 29, 2011
Last verified: December 2011

December 27, 2011
December 29, 2011
June 2011
January 2012   (final data collection date for primary outcome measure)
Implantation rate [ Time Frame: 20 days after the embryo transfer ] [ Designated as safety issue: No ]
number of embryonic sacs visible by ultrasound divided by the number of embryos transferred
Same as current
Complete list of historical versions of study NCT01501448 on ClinicalTrials.gov Archive Site
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Oral Estradiol Valerate Versus Oral Contraceptive Pill in Invitro Fertilization Patients
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The recent controversy regarding the use of pill for cycle planning in GnRH antagonists IVF cycle has driven the search for new ways to plan IVF cycles in order to avoid weekends or to equally distribute the workload. Recently, mid-late luteal phase oral estrogens seem to be as good as the pill. The investigators will compare OCP vs oral estrogens to plan the initiation of IVF cycles.

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Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Infertility
  • Drug: Levonorgestrel and ethinylestradiol
    30 microgram of ethinylestradiol plus levonorgestrel daily for 12 to 16 days
  • Drug: Estradiol valerate
    4mg estradiol valerate from cycle day 20 till the day before the initiation of the cycle
  • Active Comparator: OCP
    Intervention: Drug: Levonorgestrel and ethinylestradiol
  • Active Comparator: Oral estradiol valerate
    Intervention: Drug: Estradiol valerate
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
April 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 1st or 2nd IVF cycle
  • BMI <30 kg/m2
  • regular menstrual cycles
  • basal FSH <10IU and E2 <60pg/mL

Exclusion Criteria:

  • polycystic ovaries
  • endometriosis
  • previous ovarian surgery
  • previous low ovarian response
Female
18 Years to 38 Years
No
Contact: Juan Garcia-Velasco, MD jgvelasco@ivi.es
Spain
 
NCT01501448
IVIMAD-GV-OCPE-2011
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Instituto Valenciano de Infertilidad, Spain
Instituto Valenciano de Infertilidad, Spain
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Not Provided
Instituto Valenciano de Infertilidad, Spain
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP