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Oral Estradiol Valerate Versus Oral Contraceptive Pill in Invitro Fertilization Patients

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ClinicalTrials.gov Identifier: NCT01501448
Recruitment Status : Completed
First Posted : December 29, 2011
Last Update Posted : March 22, 2016
Sponsor:
Information provided by (Responsible Party):
IVI Madrid

Brief Summary:
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 or disease Intervention/treatment Phase
Infertility Drug: Levonorgestrel and ethinylestradiol Drug: Estradiol valerate Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2012
Actual Primary Completion Date : May 2012
Actual Study Completion Date : February 2013


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Implantation rate [ Time Frame: 20 days after the embryo transfer ]
    number of embryonic sacs visible by ultrasound divided by the number of embryos transferred



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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01501448


Locations
Spain
IVI Madrid
Madrid, Spain, 28223
Sponsors and Collaborators
IVI Madrid

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: IVI Madrid
ClinicalTrials.gov Identifier: NCT01501448     History of Changes
Other Study ID Numbers: IVIMAD-GV-OCPE-2011
First Posted: December 29, 2011    Key Record Dates
Last Update Posted: March 22, 2016
Last Verified: March 2016

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