Trial Outcomes & Findings for Endometrial Scratch Effect on Pregnancy Rates in Patients Undergoing Egg-donation IVF (NCT NCT03108157)

NCT ID: NCT03108157

Last Updated: 2020-06-23

Results Overview

Positive test (hcG\>10 UI/ml)

Recruitment status

COMPLETED

Study phase

Target enrollment

352 participants

Primary outcome timeframe

12 to 14 days after embryo transfer

Results posted on

2020-06-23

Participant Flow

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

Participant milestones

Participant milestones
Measure	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.	GROUP B: no Intervention Group Patients will receive the conventional preparation protocol to receive embryos coming from an egg donation treatment.
Overall Study STARTED	176	176
Overall Study COMPLETED	161	172
Overall Study NOT COMPLETED	15	4

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	GROUP B: no Intervention Group Patients will receive the conventional preparation protocol to receive embryos coming from an egg donation treatment.
Overall Study Protocol Violation	15	4

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GROUP A: Intervention Group n=176 Participants 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.	GROUP B: Non Intervention Group n=176 Participants Patients will receive the conventional preparation protocol to receive embryos coming from an egg donation treatment.	Total n=352 Participants Total of all reporting groups
Age, Continuous	41.29 years STANDARD_DEVIATION 4.27 • n=99 Participants	41.50 years STANDARD_DEVIATION 4.67 • n=107 Participants	41.3 years STANDARD_DEVIATION 4.5 • n=206 Participants
Sex: Female, Male Female	176 Participants n=99 Participants	176 Participants n=107 Participants	352 Participants n=206 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants	4 Participants n=107 Participants	5 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	4 Participants n=99 Participants	10 Participants n=107 Participants	14 Participants n=206 Participants
Race (NIH/OMB) White	152 Participants n=99 Participants	142 Participants n=107 Participants	294 Participants n=206 Participants
Race (NIH/OMB) More than one race	19 Participants n=99 Participants	20 Participants n=107 Participants	39 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment Spain	176 participants n=99 Participants	176 participants n=107 Participants	352 participants n=206 Participants
Smokers	34 Participants n=99 Participants	29 Participants n=107 Participants	63 Participants n=206 Participants
BMI	22.78 kg/m2 STANDARD_DEVIATION 3.39 • n=99 Participants	22.92 kg/m2 STANDARD_DEVIATION 3.31 • n=107 Participants	22.8 kg/m2 STANDARD_DEVIATION 3.3 • n=206 Participants

PRIMARY outcome

Timeframe: 12 to 14 days after embryo transfer

Positive test (hcG\>10 UI/ml)

Outcome measures

Outcome measures
Measure	GROUP A: Intervention Group n=161 Participants 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.	GROUP B: no Intervention Group n=172 Participants Patients will receive the conventional preparation protocol to receive embryos coming from an egg donation treatment.
Positive Pregnancy Test	112 Participants	113 Participants

PRIMARY outcome

Timeframe: 5 weeks of pregnancy

Ultrasound confirmation of intrauterine pregnancy

Outcome measures

Outcome measures
Measure	GROUP A: Intervention Group n=161 Participants 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.	GROUP B: no Intervention Group n=172 Participants Patients will receive the conventional preparation protocol to receive embryos coming from an egg donation treatment.
Clinical Pregnancy	104 Participants	102 Participants

SECONDARY outcome

Timeframe: Pregnancy beyond 24 weeks

Birth after 24 weeks of pregnancy

Outcome measures

Outcome measures
Measure	GROUP A: Intervention Group n=161 Participants 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.	GROUP B: no Intervention Group n=172 Participants Patients will receive the conventional preparation protocol to receive embryos coming from an egg donation treatment.
Live Birth	92 Participants	85 Participants

Adverse Events

GROUP A: Intervention Group

Serious events: 0 serious events

Other events: 36 other events

Deaths: 0 deaths

GROUP B: no Intervention Group

Serious events: 0 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	GROUP A: Intervention Group n=161 participants at risk 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.	GROUP B: no Intervention Group n=172 participants at risk Patients will receive the conventional preparation protocol to receive embryos coming from an egg donation treatment.
Pregnancy, puerperium and perinatal conditions Miscarriage	7.5% 12/161 • Adverse effects will be controlled for every patient for 12 months, starting on the day of randomization. All-Cause Mortality and Serious and Non-serious Adverse Events were monitored since all patients were followed up and contacted to assess the results of their pregnancies and determine the possible negative events. In our population no deaths or Serious Adverse Events were observed. We did not observe any Mortality or Adverse Events related to the intervention, since this intervention does not differ from conventional clinical practice.	7.0% 12/172 • Adverse effects will be controlled for every patient for 12 months, starting on the day of randomization. All-Cause Mortality and Serious and Non-serious Adverse Events were monitored since all patients were followed up and contacted to assess the results of their pregnancies and determine the possible negative events. In our population no deaths or Serious Adverse Events were observed. We did not observe any Mortality or Adverse Events related to the intervention, since this intervention does not differ from conventional clinical practice.
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	0.00% 0/161 • Adverse effects will be controlled for every patient for 12 months, starting on the day of randomization. All-Cause Mortality and Serious and Non-serious Adverse Events were monitored since all patients were followed up and contacted to assess the results of their pregnancies and determine the possible negative events. In our population no deaths or Serious Adverse Events were observed. We did not observe any Mortality or Adverse Events related to the intervention, since this intervention does not differ from conventional clinical practice.	1.7% 3/172 • Adverse effects will be controlled for every patient for 12 months, starting on the day of randomization. All-Cause Mortality and Serious and Non-serious Adverse Events were monitored since all patients were followed up and contacted to assess the results of their pregnancies and determine the possible negative events. In our population no deaths or Serious Adverse Events were observed. We did not observe any Mortality or Adverse Events related to the intervention, since this intervention does not differ from conventional clinical practice.
Pregnancy, puerperium and perinatal conditions Vanishing twin	1.9% 3/161 • Adverse effects will be controlled for every patient for 12 months, starting on the day of randomization. All-Cause Mortality and Serious and Non-serious Adverse Events were monitored since all patients were followed up and contacted to assess the results of their pregnancies and determine the possible negative events. In our population no deaths or Serious Adverse Events were observed. We did not observe any Mortality or Adverse Events related to the intervention, since this intervention does not differ from conventional clinical practice.	1.7% 3/172 • Adverse effects will be controlled for every patient for 12 months, starting on the day of randomization. All-Cause Mortality and Serious and Non-serious Adverse Events were monitored since all patients were followed up and contacted to assess the results of their pregnancies and determine the possible negative events. In our population no deaths or Serious Adverse Events were observed. We did not observe any Mortality or Adverse Events related to the intervention, since this intervention does not differ from conventional clinical practice.
Pregnancy, puerperium and perinatal conditions Placentation abnormalities	0.62% 1/161 • Adverse effects will be controlled for every patient for 12 months, starting on the day of randomization. All-Cause Mortality and Serious and Non-serious Adverse Events were monitored since all patients were followed up and contacted to assess the results of their pregnancies and determine the possible negative events. In our population no deaths or Serious Adverse Events were observed. We did not observe any Mortality or Adverse Events related to the intervention, since this intervention does not differ from conventional clinical practice.	0.00% 0/172 • Adverse effects will be controlled for every patient for 12 months, starting on the day of randomization. All-Cause Mortality and Serious and Non-serious Adverse Events were monitored since all patients were followed up and contacted to assess the results of their pregnancies and determine the possible negative events. In our population no deaths or Serious Adverse Events were observed. We did not observe any Mortality or Adverse Events related to the intervention, since this intervention does not differ from conventional clinical practice.
Pregnancy, puerperium and perinatal conditions Intrauterine growth restriction	0.00% 0/161 • Adverse effects will be controlled for every patient for 12 months, starting on the day of randomization. All-Cause Mortality and Serious and Non-serious Adverse Events were monitored since all patients were followed up and contacted to assess the results of their pregnancies and determine the possible negative events. In our population no deaths or Serious Adverse Events were observed. We did not observe any Mortality or Adverse Events related to the intervention, since this intervention does not differ from conventional clinical practice.	0.58% 1/172 • Adverse effects will be controlled for every patient for 12 months, starting on the day of randomization. All-Cause Mortality and Serious and Non-serious Adverse Events were monitored since all patients were followed up and contacted to assess the results of their pregnancies and determine the possible negative events. In our population no deaths or Serious Adverse Events were observed. We did not observe any Mortality or Adverse Events related to the intervention, since this intervention does not differ from conventional clinical practice.
Pregnancy, puerperium and perinatal conditions Preterm delivery threat	0.62% 1/161 • Adverse effects will be controlled for every patient for 12 months, starting on the day of randomization. All-Cause Mortality and Serious and Non-serious Adverse Events were monitored since all patients were followed up and contacted to assess the results of their pregnancies and determine the possible negative events. In our population no deaths or Serious Adverse Events were observed. We did not observe any Mortality or Adverse Events related to the intervention, since this intervention does not differ from conventional clinical practice.	0.00% 0/172 • Adverse effects will be controlled for every patient for 12 months, starting on the day of randomization. All-Cause Mortality and Serious and Non-serious Adverse Events were monitored since all patients were followed up and contacted to assess the results of their pregnancies and determine the possible negative events. In our population no deaths or Serious Adverse Events were observed. We did not observe any Mortality or Adverse Events related to the intervention, since this intervention does not differ from conventional clinical practice.
Pregnancy, puerperium and perinatal conditions Premature membrane rupture	0.00% 0/161 • Adverse effects will be controlled for every patient for 12 months, starting on the day of randomization. All-Cause Mortality and Serious and Non-serious Adverse Events were monitored since all patients were followed up and contacted to assess the results of their pregnancies and determine the possible negative events. In our population no deaths or Serious Adverse Events were observed. We did not observe any Mortality or Adverse Events related to the intervention, since this intervention does not differ from conventional clinical practice.	0.58% 1/172 • Adverse effects will be controlled for every patient for 12 months, starting on the day of randomization. All-Cause Mortality and Serious and Non-serious Adverse Events were monitored since all patients were followed up and contacted to assess the results of their pregnancies and determine the possible negative events. In our population no deaths or Serious Adverse Events were observed. We did not observe any Mortality or Adverse Events related to the intervention, since this intervention does not differ from conventional clinical practice.
Pregnancy, puerperium and perinatal conditions Gestational diabetes	1.2% 2/161 • Adverse effects will be controlled for every patient for 12 months, starting on the day of randomization. All-Cause Mortality and Serious and Non-serious Adverse Events were monitored since all patients were followed up and contacted to assess the results of their pregnancies and determine the possible negative events. In our population no deaths or Serious Adverse Events were observed. We did not observe any Mortality or Adverse Events related to the intervention, since this intervention does not differ from conventional clinical practice.	0.58% 1/172 • Adverse effects will be controlled for every patient for 12 months, starting on the day of randomization. All-Cause Mortality and Serious and Non-serious Adverse Events were monitored since all patients were followed up and contacted to assess the results of their pregnancies and determine the possible negative events. In our population no deaths or Serious Adverse Events were observed. We did not observe any Mortality or Adverse Events related to the intervention, since this intervention does not differ from conventional clinical practice.
Pregnancy, puerperium and perinatal conditions Pre-eclampsia	2.5% 4/161 • Adverse effects will be controlled for every patient for 12 months, starting on the day of randomization. All-Cause Mortality and Serious and Non-serious Adverse Events were monitored since all patients were followed up and contacted to assess the results of their pregnancies and determine the possible negative events. In our population no deaths or Serious Adverse Events were observed. We did not observe any Mortality or Adverse Events related to the intervention, since this intervention does not differ from conventional clinical practice.	3.5% 6/172 • Adverse effects will be controlled for every patient for 12 months, starting on the day of randomization. All-Cause Mortality and Serious and Non-serious Adverse Events were monitored since all patients were followed up and contacted to assess the results of their pregnancies and determine the possible negative events. In our population no deaths or Serious Adverse Events were observed. We did not observe any Mortality or Adverse Events related to the intervention, since this intervention does not differ from conventional clinical practice.
Pregnancy, puerperium and perinatal conditions Gestational cholestasis	0.62% 1/161 • Adverse effects will be controlled for every patient for 12 months, starting on the day of randomization. All-Cause Mortality and Serious and Non-serious Adverse Events were monitored since all patients were followed up and contacted to assess the results of their pregnancies and determine the possible negative events. In our population no deaths or Serious Adverse Events were observed. We did not observe any Mortality or Adverse Events related to the intervention, since this intervention does not differ from conventional clinical practice.	0.58% 1/172 • Adverse effects will be controlled for every patient for 12 months, starting on the day of randomization. All-Cause Mortality and Serious and Non-serious Adverse Events were monitored since all patients were followed up and contacted to assess the results of their pregnancies and determine the possible negative events. In our population no deaths or Serious Adverse Events were observed. We did not observe any Mortality or Adverse Events related to the intervention, since this intervention does not differ from conventional clinical practice.
Pregnancy, puerperium and perinatal conditions Abortion	0.00% 0/161 • Adverse effects will be controlled for every patient for 12 months, starting on the day of randomization. All-Cause Mortality and Serious and Non-serious Adverse Events were monitored since all patients were followed up and contacted to assess the results of their pregnancies and determine the possible negative events. In our population no deaths or Serious Adverse Events were observed. We did not observe any Mortality or Adverse Events related to the intervention, since this intervention does not differ from conventional clinical practice.	0.58% 1/172 • Adverse effects will be controlled for every patient for 12 months, starting on the day of randomization. All-Cause Mortality and Serious and Non-serious Adverse Events were monitored since all patients were followed up and contacted to assess the results of their pregnancies and determine the possible negative events. In our population no deaths or Serious Adverse Events were observed. We did not observe any Mortality or Adverse Events related to the intervention, since this intervention does not differ from conventional clinical practice.
Pregnancy, puerperium and perinatal conditions Preterm delivery	7.5% 12/161 • Adverse effects will be controlled for every patient for 12 months, starting on the day of randomization. All-Cause Mortality and Serious and Non-serious Adverse Events were monitored since all patients were followed up and contacted to assess the results of their pregnancies and determine the possible negative events. In our population no deaths or Serious Adverse Events were observed. We did not observe any Mortality or Adverse Events related to the intervention, since this intervention does not differ from conventional clinical practice.	9.3% 16/172 • Adverse effects will be controlled for every patient for 12 months, starting on the day of randomization. All-Cause Mortality and Serious and Non-serious Adverse Events were monitored since all patients were followed up and contacted to assess the results of their pregnancies and determine the possible negative events. In our population no deaths or Serious Adverse Events were observed. We did not observe any Mortality or Adverse Events related to the intervention, since this intervention does not differ from conventional clinical practice.
Pregnancy, puerperium and perinatal conditions 2nd twin stillbirth	0.00% 0/161 • Adverse effects will be controlled for every patient for 12 months, starting on the day of randomization. All-Cause Mortality and Serious and Non-serious Adverse Events were monitored since all patients were followed up and contacted to assess the results of their pregnancies and determine the possible negative events. In our population no deaths or Serious Adverse Events were observed. We did not observe any Mortality or Adverse Events related to the intervention, since this intervention does not differ from conventional clinical practice.	1.2% 2/172 • Adverse effects will be controlled for every patient for 12 months, starting on the day of randomization. All-Cause Mortality and Serious and Non-serious Adverse Events were monitored since all patients were followed up and contacted to assess the results of their pregnancies and determine the possible negative events. In our population no deaths or Serious Adverse Events were observed. We did not observe any Mortality or Adverse Events related to the intervention, since this intervention does not differ from conventional clinical practice.

Additional Information

Dr. Alexandra Izquierdo, Medical and Scientific Director at ProcreaTec

ProcreaTec

Phone: 0034651879266

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place