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Endometrial Scratching in In Vitro Fertilization Cycles With Oocyte Donation

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Centro de Infertilidad y Reproducción Humana
Sponsor:
Information provided by (Responsible Party):
Centro de Infertilidad y Reproducción Humana
ClinicalTrials.gov Identifier:
NCT01842178
First received: April 25, 2013
Last updated: April 26, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Subfertility
Procedure: scratching

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Randomized Prospective Study of Endometrial Injury in In Vitro Fertilization Cycles With Oocyte Donation

Further study details as provided by Centro de Infertilidad y Reproducción Humana:

Primary Outcome Measures:
  • biochemical pregnancy [ Time Frame: 14-16 days post-follicular punction ] [ Designated as safety issue: Yes ]
    Determination of human chorionic gonadotropin blood levels.


Secondary Outcome Measures:
  • Clinical pregnancy [ Time Frame: 6 pregnancy weeks ] [ Designated as safety issue: Yes ]
    Ultrasound


Other Outcome Measures:
  • Evolutionary pregnancy [ Time Frame: 12 weeks of pregnancy ] [ Designated as safety issue: Yes ]
    telephone patient contact

  • abortion [ Time Frame: 6-12 week of pregnancy ] [ Designated as safety issue: Yes ]
    telephone contact of patients


Estimated Enrollment: 200
Study Start Date: April 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: endometrial enjury
Placebo Comparator: scratching simulation
Patients will come to control visit between day 18-24. A scratching simulation will be done.

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.

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01842178

Contacts
Contact: ana perez alzueta 671679740 aperez@cirh.es

Locations
Spain
Centro de Infertilidad y Reproducción Humana Recruiting
Barcelona, Spain, 08003
Contact: ana perez alzueta, doctor    671679740    aperezalz@yahoo.es   
Contact: mario brassesco    932806535      
Principal Investigator: ana perez alzueta, gynecologist         
Sponsors and Collaborators
Centro de Infertilidad y Reproducción Humana
Investigators
Study Director: miguel angel checa CIRH
  More Information

No publications provided

Responsible Party: Centro de Infertilidad y Reproducción Humana
ClinicalTrials.gov Identifier: NCT01842178     History of Changes
Other Study ID Numbers: CIRH-OLE:2013
Study First Received: April 25, 2013
Last Updated: April 26, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

ClinicalTrials.gov processed this record on November 27, 2014