Endometrial Scratching in In Vitro Fertilization Cycles With Oocyte Donation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Prospective Study of Endometrial Injury in In Vitro Fertilization Cycles With Oocyte Donation

Conditions
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Subfertility

Intervention / Treatment
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* Procedure: scratching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Do IVF cycle with donor eggs Will adjust to protocol for the study. Have signed informed consent Exclusion Criteria: Clinically significant systemic disease, hypothalamic or pituitary tumors ovarian, uterine or breast cancer hormonal abnormalities and / or medical , biochemistry, hematology pathology, which might interfere with gonadotropin treatment. known positivity for human immunodeficiency virus (HIV), hepatitis C or B virus (HCV / HBV) of the candidate or her partner. Uterine Factor(submucosal fibroids, intramural fibroids> 4 cm) Hydrosalpinx Patients receiving immune treatment Positive Diagnosis Thrombophilia preimplantation genetic diagnosis needed In case of using marital sperm are excluded the following patients:Altered male karyotype, Altered Meiosis in testicular biopsy, Altered FISH, sperm Fragmentation> 45% Pregnancy contraindication Known allergy to preparations containing estrogens or any of its excipients. Simultaneous participation in another clinical trial with medication. Do not want or can not adjust to study protocol.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: scratching<br>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. Endometrial Injury Done between 18-24 days prior to embryo transfer cycle. Using transfer catheter. Introduction of the same to the uterine fundus. Systematic scrapping of the four uterine walls, lengthwise. Performed by a skilled doctor. Subsequent ultrasound control | Procedure: scratching<br>* Endometrial Injury Done between 18-24 days prior to embryo transfer cycle. Using transfer catheter. Introduction of the same to the uterine fundus. Systematic scrapping of the four uterine walls, lengthwise. Performed by a skilled doctor. Subsequent ultrasound control.<br>* Other names: endometrial enjury;|
| Placebo Comparator: scratching simulation<br>Patients will come to control visit between day 18-24. A scratching simulation will be done. | Procedure: scratching<br>* Endometrial Injury Done between 18-24 days prior to embryo transfer cycle. Using transfer catheter. Introduction of the same to the uterine fundus. Systematic scrapping of the four uterine walls, lengthwise. Performed by a skilled doctor. Subsequent ultrasound control.<br>* Other names: endometrial enjury;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biochemical pregnancy | Determination of human chorionic gonadotropin blood levels. | 14-16 days post-follicular punction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy | Ultrasound | 6 pregnancy weeks |