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

NCT ID: NCT01743391

Last Updated: 2022-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2018-06-30

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.

Conditions

Subfertility; Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Control

Standard treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

Office-hysteroscopy with endometrial biopsy before standard treatment

Group Type: EXPERIMENTAL

Office-hysteroscopy with biopsy

Intervention Type: PROCEDURE

Interventions

Office-hysteroscopy with biopsy

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Holbaek Sygehus

OTHER

Sponsor Role: collaborator

Hvidovre University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kristine Juul Hare

PhD, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hvidovre Hospital, Department of Gynecology and Obstetrics

Copenhagen, Hvidovre, Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 32593936 (View on PubMed)

Other Identifiers

H-4-2012-158

Identifier Type: -

Identifier Source: org_study_id