Clinical trial NCT03108157: Endometrial Scratch Effect on Pregnancy Rates in Patients Undergoing Egg-donation IVF
Official title: Endometrial Scratch Effect on Pregnancy Rates When Performed During the Previous Cycle of Embryo Transfer in Patients Undergoing Egg-donation IVF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: EMBRYO IMPLANTATION
Keywords: IVF
DONOR EGGS
ENDOMETRIAL SCRATCH
PIPELLE
ONGOING PREGNANCY
Lead sponsor: Procreatec
Sponsor class: OTHER
Collaborators: name: Hospital Universitario 12 de Octubre
First posted: 2017-04-11
Enrollment: 352
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Female undergoing IVF treatment with donor eggs

Exclusion Criteria:

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

Primary outcomes:
measure: Positive Pregnancy Test
timeFrame: 12 to 14 days after embryo transfer
measure: Clinical Pregnancy
timeFrame: 5 weeks of pregnancy
Secondary outcomes:
measure: Live Birth
timeFrame: Pregnancy beyond 24 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Procreatec
Study officials:
affiliation: Hospital Universitario 12 Octubre
name: Alberto Galindo, PhD
role: STUDY_DIRECTOR
affiliation: Hospital Universitario 12 Octubre
name: Laura De la Fuente, PhD
role: STUDY_CHAIR
References:
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