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Therapeutic Endometrial Biopsy

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ClinicalTrials.gov Identifier: NCT01963819
Recruitment Status : Unknown
Verified March 2018 by University of Aarhus.
Recruitment status was:  Recruiting
First Posted : October 16, 2013
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:

The aim of this study is to evaluate the potential benefits in implantation, clinical pregnancy and live birth rates by an endometrial biopsy prior to an IVF/ICSI treatment. Including a follow up on possible pregnancy complications and data on children at birth.

Further it is planned to aspirate secretions from the uterus and take blood samples during the treatment, which presumably can provide information about the mechanisms underlying the possible effect of the treatment.


Condition or disease Intervention/treatment Phase
Infertility Endometrium ART Endometrial Biopsy Other: Endometrial biopsy Not Applicable

Detailed Description:
Randomized controlled prospective clinical study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
No Intervention: Control
Standard treatment
Experimental: Intervention
Endometrial biopsy before standard treatment
Other: Endometrial biopsy
The endometrial biopsy will be done in the luteal phase (cycle day 18-22) prior to the treatment cycle (antagonist)
Other Names:
  • Endometrial scratching
  • Endometrial injury
  • Local injury to the endometrium




Primary Outcome Measures :
  1. Rate of clinical pregnancy [ Time Frame: Individual outcome will be evaluated within 8 weekes after embryo transfer. Overall outcome will be evaluated after 3 years. ]

Secondary Outcome Measures :
  1. Rate of biochemical pregnancy [ Time Frame: Individual outcome will be evaluated within 8 weeks after embryo transfer. Overall outcome will be evaluated after 3 years. ]
  2. Rate of implantation [ Time Frame: Individual outcome will be evaluated within 8 weekes after embryo transfer. Overall outcome will be evaluated after 3 years. ]
  3. Rate of live birth [ Time Frame: Individual outcome will be evaluated within 9 months after embryo transfer. Overall outcome will be evaluated after 3 years. ]

Other Outcome Measures:
  1. Rate of pregnancy complications [ Time Frame: Individual outcome will be evaluated within 9 months after embryo transfer. Overall outcome will be evaluated after 3 years. ]
    Placenta abnormalities, pregnancy related hypetensive disorders, IUGR, GDM

  2. Data on children and placenta at birth [ Time Frame: Individual outcome will be evaluated within 9 months after embryo transfer. Overall outcome will be evaluated after 3 years. ]
    Gestationel age, Preterm birth, LGA/SGA/NGA, Gender, Placenta abnormalities



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • One or more previous failed implantation despite transfer of good quality embryons/blastocyst in a fresh IVF/ICSI treatment
  • Planned Antagonist treatment
  • Planned Standardized hormone treatment
  • FSH: 2-12 IU/L
  • Age: 18-40 years
  • BMI: 18-32
  • Regular menstrual cycles
  • Written consent

Exclusion Criteria:

  • Patients in need for a interpreter
  • Suspected intrauterine abnormalities ( fibromes, polyps, adenomyosis, sactosalpinges)
  • Planned use og Assisted hatching or use of specialized media
  • Previous inclusion in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01963819


Contacts
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Contact: Mia Steengaard Olesen, MD +4578426562 miaolsen@rm.dk
Contact: Axel Forman, MD, DMsc axel.forman@ki.au.dk

Locations
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Denmark
Fertility Clinic, Dronninglund Hospital (Aalborg University Hospital) Recruiting
Dronninglund, Denmark
Fertility Clinic, Horsens Hospital Recruiting
Horsens, Denmark
Contact: Mia Steengaard Olesen, MD       miaolsen@rm.dk   
Fertility Clinic, Skive Hospital Recruiting
Skive, Denmark
Sponsors and Collaborators
University of Aarhus
Investigators
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Study Director: Axel Forman, MD, DMsc Departement of Gynaecology and Obstetrics, Aarhus University Hospital, Skejby
Principal Investigator: Inge E Agerholm, M.Sc, PhD Fertility Clinic, Horsens Hospital
Principal Investigator: Benedicte Hauge, MD Fertility Clinic, Horsens Hospital
Principal Investigator: Peter Humaidan, MD, DMSc Fertility Clinic, Skive Hospital
Principal Investigator: Mia Steengaard Olesen, MD Fertility Clinic Horsens Hospital, Aarhus University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01963819    
Other Study ID Numbers: Miacol-2013-1H
First Posted: October 16, 2013    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Infertility