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Endometrial Scratching in In Vitro Fertilization Cycles With Oocyte Donation

C

Centro de Infertilidad y Reproducción Humana

Status

Withdrawn

Conditions

Subfertility

Treatments

Procedure: scratching

Study type

Interventional

Funder types

Other

Identifiers

NCT01842178
CIRH-OLE:2013

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Ages

21 to 50 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

0 participants in 2 patient groups, including a placebo group

scratching
Experimental group
Description:
Patients will have an endometrial injury done on purpose, between 18-24 days prior to IVF cycle with a transfer catheter on the surgery outpatient department. 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
Treatment:
Procedure: scratching
scratching simulation
Placebo Comparator group
Description:
Patients will come to control visit between day 18-24. A scratching simulation will be done.
Treatment:
Procedure: scratching

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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