NCT01842178WithdrawnNot Applicable
Randomized Prospective Study of Endometrial Injury in In Vitro Fertilization Cycles With Oocyte Donation
Centro de Infertilidad y Reproducción Humana2 sites in 1 countryStarted: April 1, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Locations
- 2
- Primary Endpoint
- biochemical pregnancy
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 21 Years to 50 Years (Adult)
- Sex
- Female
- Accepts 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.
Outcomes
Primary Outcomes
biochemical pregnancy
Time Frame: 14-16 days post-follicular punction
Determination of human chorionic gonadotropin blood levels.
Secondary Outcomes
- Clinical pregnancy(6 pregnancy weeks)
Investigators
Study Sites (2)
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