Subfertility
Conditions
Keywords
IVF, ICSI, Embryo transfer, Assisted reproduction, Endometrial injury, Endometrial scratching
Brief summary
To examine whether endometrial scratching (or injury) using a Pipelle endometrial sampler, performed on the first seven days of the menstrual cycle, is able to improve pregnancy rates in women who will be submitted to a fresh embryo transfer.
Interventions
PROCEDUREEndometrial Scratching
The intentional damage to the endometrium performed with the objective of improving the reproductive outcomes of women desiring pregnancy.
Sponsors
Conselho Nacional de Desenvolvimento Científico e Tecnológico
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * First four days of the menstrual cycle, just before starting controlled ovarian stimulation for planned IVF and fresh embryo transfer. * Not have performed endometrial scratching in the last 90 days.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Live birth | 1 year | The number of participants who delivered a living baby in each arm. The denominator will be the number of women randomized to each arm. This outcome will be assessed by examining the medical records and telephone contact. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy | 8 weeks | The number of participants achieved clinical pregnancy detected by ultrasound (either intrauterine or ectopic). The denominator will be the number of women randomized to each arm. This outcome will be assessed by examining the medical records and telephone contact. |
| Miscarriage | 20 weeks | The number of participants who experienced spontaneous loss of a clinical pregnancy before 20 completed weeks of gestational age. The denominator will be the number of women who achieved clinical pregnancy in each arm. This outcome will be assessed by examining the medical records and telephone contact. |
| Multiple pregnancy | 8 weeks | The number of pregnant participants with more than one gestational sac (twins/triplets). The denominator will be the number of women who achieved clinical pregnancy in each arm. This outcome will be assessed by examining the medical records and telephone contact. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Implantation rate | 8 weeks | The number of gestational sacs divided by the number of transferred embryos in each arm. This outcome will be assessed by examining the medical records. |
Countries
Brazil
Outcome results
None listed