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Hysteroscopy Before in Vitro Fertilization - Does it Improve the Outcome?

This study is currently recruiting participants.
Verified April 2016 by Kristine Juul Hare, Hvidovre University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01743391
First Posted: December 6, 2012
Last Update Posted: April 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Holbaek Sygehus
Information provided by (Responsible Party):
Kristine Juul Hare, Hvidovre University Hospital
  Purpose

By randomizing sub-fertile women to either control or office-hysteroscopy in the circle prior to IVF or ICSI (intracytoplasmatic sperm injection

) treatment, we aim to enlighten whether hysteroscopy with endometrial biopsy increases pregnancy rates in the intervention group.


Condition Intervention
Subfertility Infertility Procedure: Office-hysteroscopy with biopsy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)

Resource links provided by NLM:


Further study details as provided by Kristine Juul Hare, Hvidovre University Hospital:

Primary Outcome Measures:
  • pregnancy rates [ Time Frame: individual outcome will be evaluated within 8 weeks after IVF treatment. Over all outcome will be evaluated after 3 years. ]
    Positive serum HCG and transvaginal ultrasonography, alternatively negative serum HCG and negative outcome will be registrated. After 300 women have been included final outcome will be evaluated.


Estimated Enrollment: 300
Study Start Date: January 2013
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Standard treatment
Experimental: Intervention
Office-hysteroscopy with endometrial biopsy before standard treatment
Procedure: Office-hysteroscopy with biopsy

Detailed Description:

Background A tenth of a population in Denmark today is the result of assisted fertility, including IVF and ICSI. In roughly 40 % of these subfertile women the reason is unknown. Standard initial procedures include transvaginal ultrasonography, with or without saline infusion to detect intrauterine abnormalities that might explain the infertile condition. The golden standard to detect intrauterine abnormalities is hysteroscopy. Such abnormalities can be detected in a fourth of this population. Earlier studies indicate that the hysteroscopy alone - without correcting any abnormalities, affects IVF/ISCI outcome positively.

Aim By randomizing patients referred to the fertility clinic to ±office-hysteroscopy in circle prior to IVF/ISCI, we aim to enlighten whether mini-hysteroscopy with endometrial biopsy will increase the fertility by looking at pregnancy rates as our main outcome.

Method Women signed up for second IVF/ISCI treatment will be recruited, after signed consent they are randomized to either office-hysteroscopy or nothing before standard treatment in the fertility clinic.

Mini-hysteroscopy is a standard procedure in our gynecological outpatient clinic. The procedure is done without any anesthetics. Only women with normal intrauterine conditions will be enrolled in this protocol.

When the fertility clinic has a positive serum-HCG (human chorionic gonadotropin

) and a positive transvaginal sonography, pregnancy is confirmed. If negative serum-HCG, negative pregnancy will be registered.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women submitted to IVF or ISCI treatment
  • Age > 18 years
  • Women able to read, speak and understand Danish
  • Written consent

Exclusion Criteria:

  • Intrauterine abnormalities
  • Infection
  • BMI > 35
  • Known intrauterine cause to the infertile condition
  • Abuse of alcohol or drugs
  • Untreated medical condition
  • Pregnancy
  Contacts and Locations
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): NCT01743391


Contacts
Contact: Kristine Juul Hare, MD, PhD kjhare@dadlnet.dk

Locations
Denmark
Hvidovre Hospital, Department of Gynecology and Obstetrics Recruiting
Copenhagen, Hvidovre, Denmark, 2650
Contact: Kristine Juul Hare, MD, PhD       kjhare@dadlnet.dk   
Sponsors and Collaborators
Hvidovre University Hospital
Holbaek Sygehus
  More Information

Responsible Party: Kristine Juul Hare, PhD, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01743391     History of Changes
Other Study ID Numbers: H-4-2012-158
First Submitted: December 2, 2012
First Posted: December 6, 2012
Last Update Posted: April 22, 2016
Last Verified: April 2016

Keywords provided by Kristine Juul Hare, Hvidovre University Hospital:
IVF treatment
Office-hysteroscopy
Endometrial biopsy

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female