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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Infertility
 Drug: Levonorgestrel and ethinylestradiol
Drug: Estradiol valerate
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by Instituto Valenciano de Infertilidad, Spain:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 100
Study Start Date: June 2011
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: OCP Drug: Levonorgestrel and ethinylestradiol
30 microgram of ethinylestradiol plus levonorgestrel daily for 12 to 16 days
Active Comparator: Oral estradiol valerate Drug: Estradiol valerate
4mg estradiol valerate from cycle day 20 till the day before the initiation of the cycle

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01501448

Contacts
Contact: Juan Garcia-Velasco, MD jgvelasco@ivi.es

Locations
Spain
IVI Madrid Recruiting
Madrid, Spain, 28223
Contact: Monica Toribio, RN         invesmadrid@ivi.es    
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, Spain
  More Information

No publications provided

Responsible Party: Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier: NCT01501448     History of Changes
Other Study ID Numbers: IVIMAD-GV-OCPE-2011
Study First Received: December 27, 2011
Last Updated: December 29, 2011
Health Authority: Spain: Ministerio de Sanidad

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Contraceptives, Oral
Levonorgestrel
Contraceptives, Oral, Combined
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Estradiol valerate
Estradiol 3-benzoate
 Estradiol 17 beta-cypionate
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on May 19, 2013