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OpenTrials
Completed

NCT Number: NCT00816387

Fallopian Tube Sperm Perfusion (FSP) Versus Intra-uterine Insemination (IUI) in Natural Cycle

The purpose of this study is to evaluate the efficacy of fallopian sperm perfusion (FSP) in comparison with standard intrauterine insemination (IUI) in natural cycle for couples with unexplained infertility or mild male factor.

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Key information

Conditions

Insemination, Artificial

Age range

24 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Burlo Garofolo

Trieste, 34138, Italy

About this study

A number of randomised controlled trials have been published comparing the efficacy of FSP with standard IUI. A recent meta-analysis has suggested that in couples with unexplained infertility Fallopian tube sperm perfusion together with controlled ovarian hyperstimulation (COH) leads to increased pregnancy rates than IUI and COH. No study has been published comparing the two insemination techniques in natural cycle.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • infertility for at least 2 years
  • age <40 years
  • unexplained infertility or mild male factor

Exclusion criteria

  • previous assisted reproduction treatment

Treatment and study plan

Fallopian tube sperm perfusion

Procedure

Patients are treated with fallopian tube sperm perfusion

Other names: Cervical cup

Intrauterine insemination using standard catheter

Procedure

Patients are treated with standard intrauterine insemination

Other names: Balloon catheter

Primary outcomes

  1. clinical pregnancy rate

    Time frame: 2 years

Secondary outcomes

  1. Abortion rate

    Time frame: 2 years

  2. Ectopic pregnancy rate

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

IRCCS Burlo Garofolo

Other

Registry information

Official study title

Fallopian Tube Sperm Perfusion (FSP) Versus Intra-uterine Insemination (IUI) in Natural Cycle: a Prospective Randomized Study

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jan 1, 2009
Registry last updated
Dec 3, 2010

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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