Oral Estradiol Valerate Versus Oral Contraceptive Pill in Invitro Fertilization Patients

This study has been completed.
Information provided by (Responsible Party):
IVI Madrid
ClinicalTrials.gov Identifier:
First received: December 27, 2011
Last updated: March 20, 2016
Last verified: March 2016
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
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:

Further study details as provided by IVI Madrid:

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

Enrollment: 118
Study Start Date: January 2012
Study Completion Date: February 2013
Primary Completion Date: May 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


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

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

IVI Madrid
Madrid, Spain, 28223
Sponsors and Collaborators
IVI Madrid
  More Information

Responsible Party: IVI Madrid
ClinicalTrials.gov Identifier: NCT01501448     History of Changes
Other Study ID Numbers: IVIMAD-GV-OCPE-2011 
Study First Received: December 27, 2011
Last Updated: March 20, 2016
Health Authority: Spain: Ministerio de Sanidad

Additional relevant MeSH terms:
Contraceptives, Oral
Contraceptives, Oral, Combined
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Ethinyl Estradiol
Ethinyl estradiol, levonorgestrel drug combination
Polyestradiol phosphate
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 27, 2016