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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01743391
Enrollment
220
Registered
2012-12-06
Start date
2013-01-31
Completion date
2018-06-30
Last updated
2022-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Subfertility

Keywords

IVF treatment, Office-hysteroscopy, Endometrial biopsy

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.

Interventions

PROCEDUREOffice-hysteroscopy with biopsy

Sponsors

Holbaek Sygehus
CollaboratorOTHER
Hvidovre University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
pregnancy ratesindividual 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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026