Effect of Endometrial Scratching on Assisted Reproduction Outcomes: a Randomized Controlled Trial

Study Overview
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Brief Summary
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To examine whether endometrial scratching (or injury) using a Pipelle endometrial sampler, performed on the first seven days of the menstrual cycle, is able to improve pregnancy rates in women who will be submitted to a fresh embryo transfer.

Conditions
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Subfertility

Intervention / Treatment
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* Procedure: Endometrial Scratching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years First four days of the menstrual cycle, just before starting controlled ovarian stimulation for planned IVF and fresh embryo transfer. Not have performed endometrial scratching in the last 90 days. Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endoscratching, non-RIF<br>Endometrial scratching. Women with no more than 1 previous unsuccessful embryo transfer. Pipelle in the first seven days of the menstrual cycle, just before starting controlled ovarian stimulation. | Procedure: Endometrial Scratching<br>* The intentional damage to the endometrium performed with the objective of improving the reproductive outcomes of women desiring pregnancy.<br>* Other names: Endoscratching;|
| No Intervention: Control, non-RIF<br>No intervention. Women with no more than 1 previous unsuccessful embryo transfer. | |
| Experimental: Endoscratching, RIF<br>Endometrial scratching. Women with 2 or more previous unsuccessful embryo transfers. Pipelle in the first seven days of the menstrual cycle, just before starting controlled ovarian stimulation. | Procedure: Endometrial Scratching<br>* The intentional damage to the endometrium performed with the objective of improving the reproductive outcomes of women desiring pregnancy.<br>* Other names: Endoscratching;|
| No Intervention: Control, RIF<br>No intervention. Women with 2 or more previous unsuccessful embryo transfers. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth | The number of participants who delivered a living baby in each arm. The denominator will be the number of women randomized to each arm. This outcome will be assessed by examining the medical records and telephone contact. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy | The number of participants achieved clinical pregnancy detected by ultrasound (either intrauterine or ectopic). The denominator will be the number of women randomized to each arm. This outcome will be assessed by examining the medical records and telephone contact. | 8 weeks | 
| Miscarriage | The number of participants who experienced spontaneous loss of a clinical pregnancy before 20 completed weeks of gestational age. The denominator will be the number of women who achieved clinical pregnancy in each arm. This outcome will be assessed by examining the medical records and telephone contact. | 20 weeks | 
| Multiple pregnancy | The number of pregnant participants with more than one gestational sac (twins/triplets). The denominator will be the number of women who achieved clinical pregnancy in each arm. This outcome will be assessed by examining the medical records and telephone contact. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVF, ICSI, Embryo transfer, Assisted reproduction, Endometrial injury, Endometrial scratching