Endometrial Scratching in In Vitro Fertilization Cycles With Oocyte Donation
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
|Official Title:||Randomized Prospective Study of Endometrial Injury in In Vitro Fertilization Cycles With Oocyte Donation|
- biochemical pregnancy [ Time Frame: 14-16 days post-follicular punction ] [ Designated as safety issue: Yes ]Determination of human chorionic gonadotropin blood levels.
- Clinical pregnancy [ Time Frame: 6 pregnancy weeks ] [ Designated as safety issue: Yes ]Ultrasound
- Evolutionary pregnancy [ Time Frame: 12 weeks of pregnancy ] [ Designated as safety issue: Yes ]telephone patient contact
- abortion [ Time Frame: 6-12 week of pregnancy ] [ Designated as safety issue: Yes ]telephone contact of patients
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||January 2017|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Patients will have an endometrial injury done on purpose, between 18-24 days prior to IVF cycle with a transfer catheter on the surgery outpatient department.
Other Name: endometrial enjury
Placebo Comparator: scratching simulation
Patients will come to control visit between day 18-24. A scratching simulation will be done.
This is a randomized, comparative, prospective, double Blind study.
The First stage of this study consists of revising the patients medical records to identify possible candidates. Patients indicated are randomized into two groups: experimental and control. They are followed up to 12 week of pregnancy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01842178
|Contact: Karinna Lattes Altamirano, MDfirstname.lastname@example.org|
|Centro de Infertilidad y Reproducción Humana||Recruiting|
|Barcelona, Spain, 08003|
|Contact: Karinna Lattes Altamirano, MD +342806535 email@example.com|
|Contact: Mario Brassesco, MD +342806535|
|Principal Investigator: ana perez alzueta, MD|
|Study Director:||miguel angel checa, MD||Centro de Infertilidad y Reproducción Humana|