Endometrial Scratching in In Vitro Fertilization Cycles With Oocyte Donation

NCT01842178 | Withdrawn

• 1 other identifier: CIRH-OLE:2013
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Subfertility

Outcome Measures

Primary Outcomes (1)

• biochemical pregnancy

  Determination of human chorionic gonadotropin blood levels.

  14-16 days post-follicular punction

Secondary Outcomes (1)

• Clinical pregnancy

  6 pregnancy weeks

Other Outcomes (2)

• Evolutionary pregnancy

  12 weeks of pregnancy

• abortion

  6-12 week of pregnancy

Study Arms (2)

scratching

EXPERIMENTAL

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

Procedure: scratching

scratching simulation

PLACEBO COMPARATOR

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

Procedure: scratching

Interventions

scratching 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.

Also known as: endometrial enjury

scratching; scratching simulation

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Do IVF cycle with donor eggs
• Will adjust to protocol for the study.
• Have signed informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro de Infertilidad y Reproducción Humana: lead

Study Sites (1)

Centro de Infertilidad y Reproducción Humana

Barcelona, 08003, Spain

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• miguel angel checa, MD

  Centro de Infertilidad y Reproducción Humana

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2013
• First Posted: April 29, 2013
• Study Start: April 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2017
• Last Updated: May 10, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)