An interventional study of Endometrial scratch in EMBRYO IMPLANTATION, sponsored by Procreatec. Completed at 1 site in Spain. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-23.
Sponsored by Procreatec · Not applicable, Interventional, and Treatment
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.
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.
Procreatec is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 will receive the conventional preparation protocol to receive embryos coming from an egg donation treatment.
Patients included in the study group will be performed an endometrial scratch with Pipelle Cournier 3 to 4 weeks before embryo transfer.
Also known as: Scratching
Positive Pregnancy Test
Positive test (hcG\>10 UI/ml)
Time frame: 12 to 14 days after embryo transfer
Clinical Pregnancy
Ultrasound confirmation of intrauterine pregnancy
Time frame: 5 weeks of pregnancy
Live Birth
Birth after 24 weeks of pregnancy
Time frame: Pregnancy beyond 24 weeks
Recruitment started on January 2017 and finished in October 2018. All patients were recruited at ProcreaTec Fertility Clinic in Madrid
| Milestone | GROUP A: Intervention Group | GROUP B: no Intervention Group |
|---|---|---|
| Started | 176 | 176 |
| Completed | 161 | 172 |
| Not completed | 15 | 4 |
| Withdrew: Protocol violation | 15 | 4 |
Positive test (hcG\>10 UI/ml)
| Participants | GROUP A: Intervention Group | GROUP B: no Intervention Group |
|---|---|---|
| Positive Pregnancy Test | 112 | 113 |
Ultrasound confirmation of intrauterine pregnancy
| Participants | GROUP A: Intervention Group | GROUP B: no Intervention Group |
|---|---|---|
| Clinical Pregnancy | 104 | 102 |
Birth after 24 weeks of pregnancy
| Participants | GROUP A: Intervention Group | GROUP B: no Intervention Group |
|---|---|---|
| Live Birth | 92 | 85 |
Collected over Adverse effects will be controlled for every patient for 12 months, starting on the day of randomization.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GROUP A: Intervention Group | 0/161 (0%) | 0/161 (0%) | 36/161 (22.4%) |
| GROUP B: no Intervention Group | 0/172 (0%) | 0/172 (0%) | 47/172 (27.3%) |
| Event | GROUP A: Intervention Group | GROUP B: no Intervention Group |
|---|---|---|
| Preterm deliveryPregnancy, puerperium and perinatal conditions | 12/161 | 16/172 |
| MiscarriagePregnancy, puerperium and perinatal conditions | 12/161 | 12/172 |
| Pre-eclampsiaPregnancy, puerperium and perinatal conditions | 4/161 | 6/172 |
| Vanishing twinPregnancy, puerperium and perinatal conditions | 3/161 | 3/172 |
| Ectopic pregnancyPregnancy, puerperium and perinatal conditions | 0/161 | 3/172 |
| Gestational diabetesPregnancy, puerperium and perinatal conditions | 2/161 | 1/172 |
| 2nd twin stillbirthPregnancy, puerperium and perinatal conditions | 0/161 | 2/172 |
| Placentation abnormalitiesPregnancy, puerperium and perinatal conditions | 1/161 | 0/172 |
| Preterm delivery threatPregnancy, puerperium and perinatal conditions | 1/161 | 0/172 |
| Gestational cholestasisPregnancy, puerperium and perinatal conditions | 1/161 | 1/172 |
| Age, Continuous(years) | GROUP A: Intervention Group | GROUP B: Non Intervention Group | Total |
|---|---|---|---|
| Mean | 41.29 ± 4.27 | 41.50 ± 4.67 | 41.3 ± 4.5 |
| Sex: Female, Male(Participants) | GROUP A: Intervention Group | GROUP B: Non Intervention Group | Total |
|---|---|---|---|
| Female | 176 | 176 | 352 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | GROUP A: Intervention Group | GROUP B: Non Intervention Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 4 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 10 | 14 |
| White | 152 | 142 | 294 |
| More than one race | 19 | 20 | 39 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | GROUP A: Intervention Group | GROUP B: Non Intervention Group | Total |
|---|---|---|---|
| Spain | 176 | 176 | 352 |
| Smokers(Participants) | GROUP A: Intervention Group | GROUP B: Non Intervention Group | Total |
|---|---|---|---|
| Count of participants | 34 | 29 | 63 |
| BMI(kg/m2) | GROUP A: Intervention Group | GROUP B: Non Intervention Group | Total |
|---|---|---|---|
| Mean | 22.78 ± 3.39 | 22.92 ± 3.31 | 22.8 ± 3.3 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Procreatec