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Therapeutic Endometrial Biopsy

Sponsor
University of Aarhus (Other)
Overall Status
Unknown status
CT.gov ID
NCT01963819
Collaborator
(none)
300
Enrollment
3
Locations
2
Arms
59
Duration (Months)
100
Patients Per Site
1.7
Patients Per Site Per Month

Study Details

Study Description

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
  • Other: Endometrial biopsy
 N/A

Detailed Description

Randomized controlled prospective clinical study.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Jan 1, 2014
Anticipated Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Dec 1, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Rate of clinical pregnancy [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 [Individual outcome will be evaluated within 8 weeks after embryo transfer. Overall outcome will be evaluated after 3 years.]

    2. Rate of implantation [Individual outcome will be evaluated within 8 weekes after embryo transfer. Overall outcome will be evaluated after 3 years.]

    3. Rate of live birth [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 [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 [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fertility Clinic, Dronninglund Hospital (Aalborg University Hospital) Dronninglund Denmark
    2 Fertility Clinic, Horsens Hospital Horsens Denmark
    3 Fertility Clinic, Skive Hospital Skive Denmark

    Sponsors and Collaborators

    • University of Aarhus

    Investigators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Aarhus
    ClinicalTrials.gov Identifier:
    NCT01963819
    Other Study ID Numbers:
    • Miacol-2013-1H
    First Posted:
    Oct 16, 2013
    Last Update Posted:
    Mar 19, 2018
    Last Verified:
    Mar 1, 2018
    Additional relevant MeSH terms:
    Infertility

    Study Results

    No Results Posted as of Mar 19, 2018