Embryo Implantation After Induced Endometrial Injury

NCT01955356 — Not applicable, Completed, 600 participants, Instituto Valenciano de Infertilidad, IVI VALENCIA

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Evaluation of Induced Endometrial Injury in the Subsequent IVF Cycle.

Registry	NCT01955356
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	600 (Actual)
Sponsor	Instituto Valenciano de Infertilidad, IVI VALENCIA (Other); collaborators: IVI Madrid, IVI Barcelona, IVI Murcia, Vida Recoletas Sevilla, IVI Bilbao, IVI Vigo, Instituto Valenciano de Infertilidad, IVI Alicante
Conditions	Sterility
Interventions	Scratching (Procedure)
Dates	start 2013-10-01, primary completion 2022-11-21, completion 2022-11-21, first posted 2013-10-07, last updated 2023-01-11
Locations	1 site in Spain

-Summary

Some studies have revealed that an induced endometrial injury could improve embryo human implantation in patients with implantation failure.

The purpose of this study is to determine whether the induced endometrial injury could be beneficial for regular patients undergoing IVF

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+Detailed description

Endometrial induced injury has been suggested that could improve embryo implantation in cases of patients with recurrent implantation failure. The mechanisms that induce that improvement remain unknown.

We want to analyse if the endometrial induce injury could be useful in cases of standard patients who require assisted reproductive techniques.

For that purpose we will start a randomized controlled trial with the ideal background in implantation in ART, the egg donation programme.

+Arms and interventions

Arm	Type	Interventions	Description
Scratching	Experimental	Procedure: Scratching	induced endometrial injury
No scratching	No intervention		None intervention

Scratching (Procedure), also known as Endometrial induced injury: Endometrial biopsy

+Outcome measures

Primary outcomes

Ongoing implantation rate (OIR) [12 weeks of pregnancy]

Secondary outcomes

Live born rate (LBR) [9 months after embryo transfer]

+Eligibility

Sex: Female, ages: 19 Years to 44 Years

Inclusion Criteria:

* 19-44 aged women
* 19-29.9 Kg/m2.
* 1st or 2nd fresh embryo transfer ( egg donation).
* 1 or 2 blastocysts available.
* written agreement.
* > or = 6 mms endometrial thickness.

Exclusion Criteria:

* Premature ovarian failure.
* Endometrial pathology.
* Insufficient endometrial development.
* Hydrosalpinx
* Mullerian malformations.

+Locations (1)

Facility	City	Country	Status
IVI Valencia	Valencia	Spain

+Investigators

Carmina Vidal, MD, Principal investigator, IV VALENCIA

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