Oral Estradiol Valerate Versus Oral Contraceptive Pill in Invitro Fertilization Patients
1 other identifier
interventional
118
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2012
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 27, 2011
CompletedFirst Posted
Study publicly available on registry
December 29, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedMarch 22, 2016
March 1, 2016
4 months
December 27, 2011
March 20, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Implantation rate
number of embryonic sacs visible by ultrasound divided by the number of embryos transferred
20 days after the embryo transfer
Study Arms (2)
OCP
ACTIVE COMPARATOROral estradiol valerate
ACTIVE COMPARATORInterventions
30 microgram of ethinylestradiol plus levonorgestrel daily for 12 to 16 days
4mg estradiol valerate from cycle day 20 till the day before the initiation of the cycle
Eligibility Criteria
You may qualify if:
- st or 2nd IVF cycle
- BMI \<30 kg/m2
- regular menstrual cycles
- basal FSH \<10IU and E2 \<60pg/mL
You may not qualify if:
- polycystic ovaries
- endometriosis
- previous ovarian surgery
- previous low ovarian response
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- IVI Madridlead
Study Sites (1)
IVI Madrid
Madrid, Madrid, 28223, Spain
Related Publications (1)
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.
PMID: 24074027DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 27, 2011
First Posted
December 29, 2011
Study Start
January 1, 2012
Primary Completion
May 1, 2012
Study Completion
February 1, 2013
Last Updated
March 22, 2016
Record last verified: 2016-03