Endometrial Scratching in In Vitro Fertilization Cycles With Oocyte Donation

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Subfertility
• Intervention / Treatment: Procedure: scratching

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08003
    • Centro de Infertilidad y Reproducción Humana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Procedure: 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.; Other Names: endometrial enjury
Placebo Comparator: scratching simulation; Patients will come to control visit between day 18-24. A scratching simulation will be done.	Procedure: 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.; Other Names: endometrial enjury

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
biochemical pregnancy	Determination of human chorionic gonadotropin blood levels.	14-16 days post-follicular punction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical pregnancy	Ultrasound	6 pregnancy weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolutionary pregnancy	telephone patient contact	12 weeks of pregnancy
abortion	telephone contact of patients	6-12 week of pregnancy

Collaborators and Investigators

• Sponsor: Centro de Infertilidad y Reproducción Humana
• Investigators: Study Director: miguel angel checa, MD, Centro de Infertilidad y Reproducción Humana

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Anticipated): January 1, 2016
• Study Completion (Anticipated): January 1, 2017

Study Registration Dates

• First Submitted: April 25, 2013
• First Submitted That Met QC Criteria: April 26, 2013
• First Posted (Estimate): April 29, 2013

Study Record Updates

• Last Update Posted (Actual): May 10, 2017
• Last Update Submitted That Met QC Criteria: May 9, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: CIRH-OLE:2013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO