Endometrial Scratch Effect on Pregnancy Rates in Patients Undergoing Egg-donation IVF
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|ClinicalTrials.gov Identifier: NCT03108157|
Recruitment Status : Recruiting
First Posted : April 11, 2017
Last Update Posted : April 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|EMBRYO IMPLANTATION||Procedure: Endometrial scratch||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||332 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Endometrial Scratch Effect on Pregnancy Rates When Performed During the Previous Cycle of Embryo Transfer in Patients Undergoing Egg-donation IVF|
|Actual Study Start Date :||January 30, 2017|
|Estimated Primary Completion Date :||December 31, 2017|
|Estimated Study Completion Date :||June 30, 2018|
Experimental: STUDY GROUP
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
Patients included in the study group will be performed an endometrial scratch with Pipelle Cournier 3 to 4 weeks before embryo transfer.
Other Name: Scratching
No Intervention: CONTROL GROUP
Patients will receive the conventional preparation protocol to receive embryos coming from an egg donation treatment.
- Pregnancy Rate [ Time Frame: 12 to 14 days after the embryo transfer ]Positive pregnancy test in blood
- Ongoing Pregnancy Rate [ Time Frame: 15 days after the pregnancy test ]US confirmation of evolutive pregnancy
- Miscarriage Rate [ Time Frame: Before week 12 of pregnancy ]Pregnancy loss
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03108157
|Contact: Alexandra Izquierdo, MD||0034914585804 ext firstname.lastname@example.org|
|Contact: Katharina Spies, MD||0034914585804 ext email@example.com|
|Madrid, Spain, 28036|
|Contact: Alexandra Izquierdo, MD 0034914585804 ext 28 firstname.lastname@example.org|
|Contact: Katharina Spies, MD 0034914585804 ext 28 email@example.com|
|Study Director:||Alberto Galindo, PhD||Hospital Universitario 12 Octubre|
|Study Chair:||Laura De la Fuente, PhD||Hospital Universitario 12 Octubre|