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

Endometrial Scratch Effect on Pregnancy Rates When Performed During the Previous Cycle of Embryo Transfer in Patients Undergoing Egg-donation IVF

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03108157
Enrollment
352
Registered
2017-04-11
Start date
2017-01-12
Completion date
2019-12-31
Last updated
2020-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

EMBRYO IMPLANTATION

Keywords

IVF, DONOR EGGS, ENDOMETRIAL SCRATCH, PIPELLE, ONGOING PREGNANCY

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.

Interventions

PROCEDUREEndometrial scratch

Patients included in the study group will be performed an endometrial scratch with Pipelle Cournier 3 to 4 weeks before embryo transfer.

Sponsors

Hospital Universitario 12 de Octubre
CollaboratorOTHER
Procreatec
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Female undergoing IVF treatment with donor eggs

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Positive Pregnancy Test12 to 14 days after embryo transferPositive test (hcG\>10 UI/ml)
Clinical Pregnancy5 weeks of pregnancyUltrasound confirmation of intrauterine pregnancy

Secondary

MeasureTime frameDescription
Live BirthPregnancy beyond 24 weeksBirth after 24 weeks of pregnancy

Countries

Spain

Participant flow

Recruitment details

Recruitment started on January 2017 and finished in October 2018. All patients were recruited at ProcreaTec Fertility Clinic in Madrid

Participants by arm

ArmCount
GROUP A: Intervention 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.
176
GROUP B: Non Intervention Group
Patients will receive the conventional preparation protocol to receive embryos coming from an egg donation treatment.
176
Total352

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyProtocol Violation154

Baseline characteristics

CharacteristicGROUP A: Intervention GroupGROUP B: Non Intervention GroupTotal
Age, Continuous41.29 years
STANDARD_DEVIATION 4.27
41.50 years
STANDARD_DEVIATION 4.67
41.3 years
STANDARD_DEVIATION 4.5
BMI22.78 kg/m2
STANDARD_DEVIATION 3.39
22.92 kg/m2
STANDARD_DEVIATION 3.31
22.8 kg/m2
STANDARD_DEVIATION 3.3
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants4 Participants5 Participants
Race (NIH/OMB)
Black or African American
4 Participants10 Participants14 Participants
Race (NIH/OMB)
More than one race
19 Participants20 Participants39 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
152 Participants142 Participants294 Participants
Region of Enrollment
Spain
176 participants176 participants352 participants
Sex: Female, Male
Female
176 Participants176 Participants352 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants
Smokers34 Participants29 Participants63 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1610 / 172
other
Total, other adverse events
36 / 16147 / 172
serious
Total, serious adverse events
0 / 1610 / 172

Outcome results

Primary

Clinical Pregnancy

Ultrasound confirmation of intrauterine pregnancy

Time frame: 5 weeks of pregnancy

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
GROUP A: Intervention GroupClinical Pregnancy104 Participants
GROUP B: no Intervention GroupClinical Pregnancy102 Participants
Primary

Positive Pregnancy Test

Positive test (hcG\>10 UI/ml)

Time frame: 12 to 14 days after embryo transfer

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
GROUP A: Intervention GroupPositive Pregnancy Test112 Participants
GROUP B: no Intervention GroupPositive Pregnancy Test113 Participants
Secondary

Live Birth

Birth after 24 weeks of pregnancy

Time frame: Pregnancy beyond 24 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
GROUP A: Intervention GroupLive Birth92 Participants
GROUP B: no Intervention GroupLive Birth85 Participants

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026