Back to resultsEndometrial Priming for Embryo Transfer
Primary Purpose
Sterility
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Oral strogen
Transdermal strogen
Sponsored by
About this trial
This is an interventional treatment trial for Sterility focused on measuring Oral estrogens, transdermal estrogens, endometrial priming
Eligibility Criteria
Inclusion Criteria:
- Women between 18-50 years old with desire of children and needs of embryo transfer.
- Plasma prolactin less than 30.
- Uterine cavity that allow pregnancy, body mass index between 20-30.
- And signed consent inform.
Exclusion Criteria:
- History of estrogen dependent cancer, unknown origin vaginal bleeding.
- Ovarian cyst.
- Contraindications to be pregnant.
- Estrogen allergy.
Sites / Locations
- Hospital del Mar
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Oral strogen
Transdermal strogen
Arm Description
Outcomes
Primary Outcome Measures
Difference between day means in endometrial priming to achieve 7 mm.
Secondary Outcome Measures
Biochemical Pregnancy rate
To calculate the biochemical pregnancy rate, we will divide the number of biochemical pregnancy into the number of embryonary transference and multiply by 100.
The patient's adherence to the recommended treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01430650
Brief Title
Endometrial Priming for Embryo Transfer
Official Title
A Randomised Control Trial to Evaluate Efficacy and Safety of Two Different Protocols of Endometrial Priming for Embryo Transfer.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Parc de Salut Mar
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this trial is compare two different endometrial priming protocols
women that receive oral estrogens
women that receive transdermal estrogens
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sterility
Keywords
Oral estrogens, transdermal estrogens, endometrial priming
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oral strogen
Arm Type
Experimental
Arm Title
Transdermal strogen
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Oral strogen
Intervention Description
2 mg of estradiol every day beginning the second day of the cycle until day 7. 4 mg of estradiol every day beginning 8th day of the cycle until day 10. 6 mg of estradiol every day beginning 11th day of the cycle until day 16.
Intervention Type
Drug
Intervention Name(s)
Transdermal strogen
Intervention Description
One patch of 75 mcg of estradiol hemimydrate every 48 h from 2 to day 6. Two patches of 75 mcg of estradiol hemimydrate every 48 h from 6 to day 12. Three patches of 75 mcg of estradiol hemimydrate every 48 h from 12 to day 16.
Primary Outcome Measure Information:
Title
Difference between day means in endometrial priming to achieve 7 mm.
Time Frame
11-16 days
Secondary Outcome Measure Information:
Title
Biochemical Pregnancy rate
Description
To calculate the biochemical pregnancy rate, we will divide the number of biochemical pregnancy into the number of embryonary transference and multiply by 100.
Time Frame
26-30 days
Title
The patient's adherence to the recommended treatment.
Time Frame
1-16 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women between 18-50 years old with desire of children and needs of embryo transfer.
Plasma prolactin less than 30.
Uterine cavity that allow pregnancy, body mass index between 20-30.
And signed consent inform.
Exclusion Criteria:
History of estrogen dependent cancer, unknown origin vaginal bleeding.
Ovarian cyst.
Contraindications to be pregnant.
Estrogen allergy.
Facility Information:
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
12. IPD Sharing Statement
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Endometrial Priming for Embryo Transfer
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