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OpenTrials
Completed

NCT Number: NCT01743391

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hvidovre Hospital, Department of Gynecology and Obstetrics

Copenhagen, Hvidovre, 2650, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Office-hysteroscopy with biopsy

Procedure

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Collaborators

  • Holbaek Sygehus

Registry information

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Dec 6, 2012
Registry last updated
Mar 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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