Endometrial Scratching in In Vitro Fertilization Cycles With Oocyte Donation

NCT ID: NCT01842178

Last Updated: 2017-05-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2017-01-31

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.

Conditions

Subfertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

scratching

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

Group Type: EXPERIMENTAL

scratching

Intervention Type: PROCEDURE

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.

scratching simulation

Patients will come to control visit between day 18-24. A scratching simulation will be done.

Group Type: PLACEBO_COMPARATOR

scratching

Intervention Type: PROCEDURE

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.

Interventions

scratching

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.

Intervention Type: PROCEDURE

Other Intervention Names

endometrial enjury

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centro de Infertilidad y Reproducción Humana

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

miguel angel checa, MD

Role: STUDY_DIRECTOR

Centro de Infertilidad y Reproducción Humana

Locations

Centro de Infertilidad y Reproducción Humana

Barcelona, , Spain

Countries

Spain

Other Identifiers

CIRH-OLE:2013

Identifier Type: -

Identifier Source: org_study_id