Subfertility
Conditions
Brief summary
This study is designed to evaluate the potential benefit in pregnancy rates produced by an endometrial scratching made in an IVF cycle prior to embryo transfer in patients with donated oocytes.
Detailed description
This is a randomized, comparative, prospective, double Blind study. The First stage of this study consists of revising the patients medical records to identify possible candidates. Patients indicated are randomized into two groups: experimental and control. They are followed up to 12 week of pregnancy.
Interventions
PROCEDUREscratching
Endometrial Injury * Done between 18-24 days prior to embryo transfer cycle. * Using transfer catheter. * Introduction of the same to the uterine fundus. * Systematic scrapping of the four uterine walls, lengthwise. * Performed by a skilled doctor. * Subsequent ultrasound control.
Sponsors
Centro de Infertilidad y Reproducción Humana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Do IVF cycle with donor eggs * Will adjust to protocol for the study. * Have signed informed consent
Exclusion criteria
* Clinically significant systemic disease, hypothalamic or pituitary tumors * ovarian, uterine or breast cancer * hormonal abnormalities and / or medical , biochemistry, hematology pathology, which might interfere with gonadotropin treatment. * known positivity for human immunodeficiency virus (HIV), hepatitis C or B virus (HCV / HBV) of the candidate or her partner. * Uterine Factor(submucosal fibroids, intramural fibroids\> 4 cm) * Hydrosalpinx * Patients receiving immune treatment * Positive Diagnosis Thrombophilia * preimplantation genetic diagnosis needed * In case of using marital sperm are excluded the following patients:Altered male karyotype, Altered Meiosis in testicular biopsy, Altered FISH, sperm Fragmentation\> 45% * Pregnancy contraindication * Known allergy to preparations containing estrogens or any of its excipients. * Simultaneous participation in another clinical trial with medication. * Do not want or can not adjust to study protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| biochemical pregnancy | 14-16 days post-follicular punction | Determination of human chorionic gonadotropin blood levels. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy | 6 pregnancy weeks | Ultrasound |
Other
| Measure | Time frame | Description |
|---|---|---|
| Evolutionary pregnancy | 12 weeks of pregnancy | telephone patient contact |
| abortion | 6-12 week of pregnancy | telephone contact of patients |
Countries
Spain
Outcome results
None listed