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Endometrial Scratching in In Vitro Fertilization Cycles With Oocyte Donation

Primary Purpose

Subfertility

Status
Withdrawn
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
scratching
Sponsored by
Centro de Infertilidad y Reproducción Humana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subfertility

Eligibility Criteria

21 Years - 50 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • Centro de Infertilidad y Reproducción Humana

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

scratching

scratching simulation

Arm 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

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

Outcomes

Primary Outcome Measures

biochemical pregnancy
Determination of human chorionic gonadotropin blood levels.

Secondary Outcome Measures

Clinical pregnancy
Ultrasound

Full Information

First Posted
April 25, 2013
Last Updated
May 9, 2017
Sponsor
Centro de Infertilidad y Reproducción Humana
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1. Study Identification

Unique Protocol Identification Number
NCT01842178
Brief Title
Endometrial Scratching in In Vitro Fertilization Cycles With Oocyte Donation
Official Title
Randomized Prospective Study of Endometrial Injury in In Vitro Fertilization Cycles With Oocyte Donation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Principal investigator retired from the project
Study Start Date
April 2013 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centro de Infertilidad y Reproducción Humana

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subfertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
scratching
Arm Type
Experimental
Arm 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
Arm Title
scratching simulation
Arm Type
Placebo Comparator
Arm Description
Patients will come to control visit between day 18-24. A scratching simulation will be done.
Intervention Type
Procedure
Intervention Name(s)
scratching
Other Intervention Name(s)
endometrial enjury
Intervention Description
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.
Primary Outcome Measure Information:
Title
biochemical pregnancy
Description
Determination of human chorionic gonadotropin blood levels.
Time Frame
14-16 days post-follicular punction
Secondary Outcome Measure Information:
Title
Clinical pregnancy
Description
Ultrasound
Time Frame
6 pregnancy weeks
Other Pre-specified Outcome Measures:
Title
Evolutionary pregnancy
Description
telephone patient contact
Time Frame
12 weeks of pregnancy
Title
abortion
Description
telephone contact of patients
Time Frame
6-12 week of pregnancy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
miguel angel checa, MD
Organizational Affiliation
Centro de Infertilidad y Reproducción Humana
Official's Role
Study Director
Facility Information:
Facility Name
Centro de Infertilidad y Reproducción Humana
City
Barcelona
ZIP/Postal Code
08003
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Endometrial Scratching in In Vitro Fertilization Cycles With Oocyte Donation

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