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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

Tracking Information
First Submitted Date  ICMJE October 11, 2013
First Posted Date  ICMJE October 16, 2013
Last Update Posted Date March 19, 2018
Study Start Date  ICMJE January 2014
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2013)
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. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2013)
  • 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. ]
  • Rate of implantation [ Time Frame: Individual outcome will be evaluated within 8 weekes after embryo transfer. Overall outcome will be evaluated after 3 years. ]
  • 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. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 11, 2013)
  • 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
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Therapeutic Endometrial Biopsy
Official Title  ICMJE Not Provided
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.

Detailed Description Randomized controlled prospective clinical study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Infertility
  • Endometrium
  • ART
  • Endometrial Biopsy
Intervention  ICMJE 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
Study Arms  ICMJE
  • No Intervention: Control
    Standard treatment
  • Experimental: Intervention
    Endometrial biopsy before standard treatment
    Intervention: Other: Endometrial biopsy
Publications * Olesen MS, Hauge B, Ohrt L, Olesen TN, Roskær J, Bæk V, Elbæk HO, Nøhr B, Nyegaard M, Overgaard MT, Humaidan P, Forman A, Agerholm I. Therapeutic endometrial scratching and implantation after in vitro fertilization: a multicenter randomized controlled trial. Fertil Steril. 2019 Dec;112(6):1015-1021. doi: 10.1016/j.fertnstert.2019.08.010.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 15, 2018)
300
Original Estimated Enrollment  ICMJE
 (submitted: October 11, 2013)
250
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01963819
Other Study ID Numbers  ICMJE Miacol-2013-1H
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Aarhus
Study Sponsor  ICMJE University of Aarhus
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account University of Aarhus
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP