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

Not Applicable

Completed

• Conditions: EMBRYO IMPLANTATION
• Interventions: Procedure: Endometrial scratch

• Registration Number: NCT03108157
• Lead Sponsor: Procreatec

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-01-12
• Study First Submitted: 2017-04-05
• Study First Submitted QC: 2017-04-10
• Study First Posted: 2017-04-11
• Primary Completion: 2018-11-30
• Results First Submitted: 2019-08-08
• Results First Submitted QC: 2019-11-14
• Results First Posted: 2019-12-04
• Study Completion: 2019-12-31
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-10
• Last Update Posted: 2020-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 352

Inclusion Criteria

• Female undergoing IVF treatment with donor eggs

Exclusion Criteria

• Severe male factor ( less tan 2 million spermatozoa per ml )
• Uterine abnormalities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GROUP A: intervention group	Endometrial scratch	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.

Primary Outcome Measures

Name	Time	Method
Positive Pregnancy Test	12 to 14 days after embryo transfer	Positive test (hcG\>10 UI/ml)
Clinical Pregnancy	5 weeks of pregnancy	Ultrasound confirmation of intrauterine pregnancy

Secondary Outcome Measures

Name	Time	Method
Live Birth	Pregnancy beyond 24 weeks	Birth after 24 weeks of pregnancy

Trial Locations

Locations (1)

Procreatec; 🇪🇸 Madrid, Spain