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

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ClinicalTrials.gov Identifier: NCT01743391
Recruitment Status : Unknown
Verified April 2016 by Kristine Juul Hare, Hvidovre University Hospital.
Recruitment status was:  Recruiting
First Posted : December 6, 2012
Last Update Posted : April 22, 2016
Sponsor:
Collaborator:
Holbaek Sygehus
Information provided by (Responsible Party):
Kristine Juul Hare, Hvidovre University Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Subfertility Infertility Procedure: Office-hysteroscopy with biopsy Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Study Start Date : January 2013
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Control
Standard treatment
Experimental: Intervention
Office-hysteroscopy with endometrial biopsy before standard treatment
Procedure: Office-hysteroscopy with biopsy



Primary Outcome Measures :
  1. 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.



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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

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

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 Posted: December 6, 2012    Key Record Dates
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