Endometrial Scratching in In Vitro Fertilization Cycles With Oocyte Donation
This study is designed to evaluate the potential benefit in pregnancy rates produced by an endometrial scratching made in an IVF cycle prior to embryo transfer in patients with donated oocytes.
|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 2016|
|Estimated Primary Completion Date:||October 2015 (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: ana perez firstname.lastname@example.org|
|Centro de Infertilidad y Reproducción Humana||Recruiting|
|Barcelona, Spain, 08003|
|Contact: ana perez alzueta, doctor 671679740 email@example.com|
|Contact: mario brassesco 932806535|
|Principal Investigator: ana perez alzueta, gynecologist|
|Study Director:||miguel angel checa||CIRH|