Intrauterine Insemination Predictor Factors

Infertility Clinical Trial

Official title:

Retrospective Evaluation of Clinical Predictors of Pregnancy and Live-birth After Homologous Intrauterine Insemination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03836118
• Other study ID #: 7/18
• Status: Completed
• Start date: January 1, 1997
• Est. completion date: August 31, 2018

Study information

• Verified date: February 2019
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2970
• Est. completion date: August 31, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Procedure:
• Homologous intrauterine insemination (IUI)
Patients were treated with HMG/rFSH according to classic protocols of therapy and monitoring. An injection of uHCG 5000 IU/ rHCG 250 mg was given to trigger ovulation. On the day of insemination, the semen sample was obtained through masturbation after a 2-5 day abstinence period and collected in a sterile cup. TMSC was determined by multiplying grade A or grade A + B sperm motility percentages by sperm volume and concentration. To evaluate sperm viability Eosin and Nigrosin (E&N) staining was carried out according to WHO standards. Sperm capacitation was performed using density gradient centrifugation or swim-up procedure in order to remove seminal fluids and enhance sperm quality for IUI. IUI was performed a t36 hours post-HCG. A fraction of the washed motile spermatozoa was inserted up to the uterine fundus and expelled into the uterine cavity. Daily treatment with micronized progesterone was prescribed for 14 days after IUI. Serum ß-HCG was determined 14 days after IUI.

Locations

Country	Name	City	State
Italy	Paolo Emanuele Levi Setti	Rozzano	MI

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical pregnancy rate (CPR)		1997-2017
Primary	live-birth rate (LBR)		1997 - 2017