Clinical trial NCT01743391: Hysteroscopy Before in Vitro Fertilization - Does it Improve the Outcome?
Official title: Hysteroscopy Before in Vitro Fertilization - Does it Improve the Outcome?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subfertility
Infertility
Keywords: IVF treatment
Office-hysteroscopy
Endometrial biopsy
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: Holbaek Sygehus
First posted: 2012-12-06
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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 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

Primary outcomes:
measure: pregnancy rates
timeFrame: individual outcome will be evaluated within 8 weeks after IVF treatment. Over all outcome will be evaluated after 3 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Hvidovre Hospital, Department of Gynecology and Obstetrics
state: Hvidovre
Study officials:
References:
citation: Berntsen S, Hare KJ, Lossl K, Bogstad J, Palmo J, Praetorius L, Zedeler A, Pinborg A. Endometrial scratch injury with office hysteroscopy before IVF/ICSI: A randomised controlled trial. Eur J Obstet Gynecol Reprod Biol. 2020 Sep;252:112-117. doi: 10.1016/j.ejogrb.2020.06.034. Epub 2020 Jun 17.