Hysteroscopy Before in Vitro Fertilization - Does it Improve the Outcome?
|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.|
|ClinicalTrials.gov Identifier: NCT01743391|
Recruitment Status : Recruiting
First Posted : December 6, 2012
Last Update Posted : April 22, 2016
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|
|Subfertility Infertility||Procedure: Office-hysteroscopy with biopsy|
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|
|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|
No Intervention: Control
Office-hysteroscopy with endometrial biopsy before standard treatment
|Procedure: Office-hysteroscopy with biopsy|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01743391
|Contact: Kristine Juul Hare, MD, PhDfirstname.lastname@example.org|
|Hvidovre Hospital, Department of Gynecology and Obstetrics||Recruiting|
|Copenhagen, Hvidovre, Denmark, 2650|
|Contact: Kristine Juul Hare, MD, PhD email@example.com|