Endometrial Scratch Effect on Pregnancy Rates in Patients Undergoing Egg-donation IVF

Study Overview
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Brief Summary
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Clinical trial about the effect of endometrial scratch on pregnancy rates in patients undergoing a treatment with in-vitro fertilization with donor eggs, when doing the endometrial biopsy during the cycle prior to the embryo transfer.

Detailed Description
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The aim of this clinical trial is to investigate whether an endometrial scratch during the cycle prior to embryo transfer cycle is effective or not in increasing pregnancy rates. Previous studies about this issue have not shown clear conclusions about the effectiveness of this method. The endometrial scratch is a simple technique that consists in performing a mild injury to all the internal walls of the uterus with a Pipelle Cournier. To achieve the trial objective, all participating patients are randomly divided into two groups. Once patients decide to participate in the trial, they are assigned to each group according to the randomization list: Group A: Patients with transfer of fresh embryos after taking an endometrium biopsy during the previous cycle and then following the conventional preparation protocol. Group B: Patients with transfer of fresh embryos with the conventional preparation protocol.

Official Title
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Endometrial Scratch Effect on Pregnancy Rates When Performed During the Previous Cycle of Embryo Transfer in Patients Undergoing Egg-donation IVF

Conditions
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EMBRYO IMPLANTATION

Intervention / Treatment
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* Procedure: Endometrial scratch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female undergoing IVF treatment with donor eggs Exclusion Criteria: Severe male factor ( less tan 2 million spermatozoa per ml ) Uterine abnormalities

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GROUP A: intervention group<br>Patients will be performed an endometrial scratch with Pipelle Cournier 3 to 4 weeks before the embryo transfer and then they will follow the conventional preparation protocol to receive embryos coming from an egg donation treatment. | Procedure: Endometrial scratch<br>* Patients included in the study group will be performed an endometrial scratch with Pipelle Cournier 3 to 4 weeks before embryo transfer.<br>* Other names: Scratching;|
| No Intervention: GROUP B: no intervention group<br>Patients will receive the conventional preparation protocol to receive embryos coming from an egg donation treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive Pregnancy Test | Positive test (hcG>10 UI/ml) | 12 to 14 days after embryo transfer | 
| Clinical Pregnancy | Ultrasound confirmation of intrauterine pregnancy | 5 weeks of pregnancy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live Birth | Birth after 24 weeks of pregnancy | Pregnancy beyond 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DONOR EGGS, ENDOMETRIAL SCRATCH, PIPELLE, ONGOING PREGNANCY, IVF