Back to resultsOral Estradiol Valerate Versus Oral Contraceptive Pill in Invitro Fertilization Patients
Primary Purpose
Infertility
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Levonorgestrel and ethinylestradiol
Estradiol valerate
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility 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
Sites / Locations
- IVI Madrid
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
OCP
Oral estradiol valerate
Arm Description
Outcomes
Primary Outcome Measures
Implantation rate
number of embryonic sacs visible by ultrasound divided by the number of embryos transferred
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01501448
Brief Title
Oral Estradiol Valerate Versus Oral Contraceptive Pill in Invitro Fertilization Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IVI Madrid
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
118 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OCP
Arm Type
Active Comparator
Arm Title
Oral estradiol valerate
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Levonorgestrel and ethinylestradiol
Intervention Description
30 microgram of ethinylestradiol plus levonorgestrel daily for 12 to 16 days
Intervention Type
Drug
Intervention Name(s)
Estradiol valerate
Intervention Description
4mg estradiol valerate from cycle day 20 till the day before the initiation of the cycle
Primary Outcome Measure Information:
Title
Implantation rate
Description
number of embryonic sacs visible by ultrasound divided by the number of embryos transferred
Time Frame
20 days after the embryo transfer
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
IVI Madrid
City
Madrid
ZIP/Postal Code
28223
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
24074027
Citation
Hauzman EE, Zapata A, Bermejo A, Iglesias C, Pellicer A, Garcia-Velasco JA. Cycle scheduling for in vitro fertilization with oral contraceptive pills versus oral estradiol valerate: a randomized, controlled trial. Reprod Biol Endocrinol. 2013 Sep 28;11:96. doi: 10.1186/1477-7827-11-96.
Results Reference
derived
Learn more about this trial
Oral Estradiol Valerate Versus Oral Contraceptive Pill in Invitro Fertilization Patients
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