Intrauterine Insemination Predictor Factors

Completed

• Conditions: Infertility
• Interventions: Procedure: Homologous intrauterine insemination (IUI)

• Registration Number: NCT03836118
• Lead Sponsor: Istituto Clinico Humanitas

Brief Summary

Multiple studies have reported on the impact of factors such as female age, duration of infertility, type of infertility, hormone levels (i.e. AMH, FSH, estradiol, progesterone), use of different ovarian stimulation protocols, timing/induction of ovulation, number of pre-ovulatory follicles, endometrial thickness by the time of ovulation, sperm parameters (i.e. concentration, progressive motility, morphology, total motile sperm count \[TMSC\], inseminating motile count \[IMC\]) and sperm washing procedures. Also the influence of body mass index and smoking on IUI outcome have been studied before. However, results on the predictive value of these parameters remain highly contradictory. The aim of the study is to examine the value of different variables in the prediction of IUI success to develop a clinically useful predictive model of pregnancy and live birth.

Detailed Description

Not available

Study Timeline

• Study Start: 1997-01-01
• Primary Completion: 2017-12-31
• Study Completion: 2018-08-31
• Status Verified: 2019-02
• Study First Submitted: 2019-02-08
• Study First Submitted QC: 2019-02-08
• Last Update Submitted: 2019-02-08
• Study First Posted: 2019-02-11
• Last Update Posted: 2019-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2970

Inclusion Criteria

• couples had been diagnosed with infertility according to WHO definition (failure to achieve a clinical pregnancy after 12 months or more of regular unprotected sexual intercourse)
• at least one permeable tube
• a motile sperm concentration post treatment of 1×106/mL on the day of the semen analysis

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IUI	Homologous intrauterine insemination (IUI)	all the IUI with controlled ovarian stimulation cycles in an academic tertiary ART center between January 1997 and December 2017

Primary Outcome Measures

Name	Time	Method
live-birth rate (LBR)	1997 - 2017
clinical pregnancy rate (CPR)	1997-2017

Trial Locations

Locations (1)

Paolo Emanuele Levi Setti; 🇮🇹 Rozzano, MI, Italy