Recurrent Implantation Failure in Setting of Artifically Prepared Endometrium
Conditions
Keywords
recurrent implantation failure, frozen embryo transfer, IVF, endometrial scratch, endometrial injury
Brief summary
Patients with a history of recurrent implantation failure who are planning a frozen embryo transfer (FET) are enrolled into the program. Patients are randomized to an endometrial biopsy prior to starting estrogen to prepare for the transfer of warmed vitrified embryos or to routine care.
Detailed description
Patients who failed to achieve a clinical pregnancy after embryo transfer of at least three high quality embryos in at least two IVF or FET cycles and for whom their last failed cycle was a frozen embryo transfer are offered the opportunity to enroll in this study. All patients will follow our routine FET protocol. On a randomized basis, selected patients will undergo an endometrial biopsy using a Pipelle disposable device in the week prior to starting estrogen to prepare her endometrium.
Interventions
PROCEDUREendometrial biopsy
endometrial biopsy
Sponsors
Brown Fertility
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* At least two prior consecutive failed IVF or FET cycles with transfer of at least 3 high quality embryos and with last cycle a FET cycle
Exclusion criteria
* Alternate explanation for implantation failure (e.g., intrauterine pathology)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implantation rate | within 6 months after recruitment | Sacs seen in early ultrasound divided by the number of embryos transferred |
| clinical pregnancy rate | within 6 months after recruitment | Number of patients with ultrasound evidence of pregnancy divided by the number of embryo transfers |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ongoing pregnancy rate | within 18 months of recruitment | Viable or delivered pregnancies at conclusion of study divided by the number of embryo transfers |
| biochemical pregnancy rate | within 6 months after recruitment | number of positive pregnancy test divided by number of embryo transfers |
| miscarriage rate | within 18 months after recruitment | number of losses of clinical pregnancies divided by number of clinical pregnancies |
Outcome results
None listed