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Randomized Prospective Study of Endometrial Injury in In Vitro Fertilization Cycles With Oocyte Donation


N/A
21 Years
50 Years
Open (Enrolling)
Female
Subfertility

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Trial Information

Randomized Prospective Study of Endometrial Injury in In Vitro Fertilization Cycles With Oocyte Donation


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Outcome Measure:

biochemical pregnancy

Outcome Description:

Determination of human chorionic gonadotropin blood levels.

Outcome Time Frame:

14-16 days post-follicular punction

Safety Issue:

Yes

Principal Investigator

miguel angel checa

Investigator Role:

Study Director

Investigator Affiliation:

CIRH

Authority:

Spain: Comité Ético de Investigación Clínica

Study ID:

CIRH-OLE:2013

NCT ID:

NCT01842178

Start Date:

April 2013

Completion Date:

January 2016

Related Keywords:

  • Subfertility
  • Adenoma
  • Infertility

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