Intrauterine Insemination Predictor Factors

February 8, 2019 updated by: Istituto Clinico Humanitas

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2970

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • MI
      • Rozzano, MI, Italy, 20089
        • Paolo Emanuele Levi Setti

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The included couples were subjected to an infertility diagnostic work-up. The tests included collecting medical history, physical examination, transvaginal ultrasound, serum hormone assays between day 2 and 4 of the menstrual cycle, semen analysis, uterine cavity and tubal patency evaluation with hysterosalpingography (HSG) or hysterosonosalpingography (HSSG) and/or hysteroscopy and video laparoscopy. Assessment of vaginal infection with cervico-vaginal swab and cultures

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
IUI
all the IUI with controlled ovarian stimulation cycles in an academic tertiary ART center between January 1997 and December 2017
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
clinical pregnancy rate (CPR)
Time Frame: 1997-2017
1997-2017
live-birth rate (LBR)
Time Frame: 1997 - 2017
1997 - 2017

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Clinico Humanitas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 1997

Primary Completion (ACTUAL)

December 31, 2017

Study Completion (ACTUAL)

August 31, 2018

Study Registration Dates

First Submitted

February 8, 2019

First Submitted That Met QC Criteria

February 8, 2019

First Posted (ACTUAL)

February 11, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 11, 2019

Last Update Submitted That Met QC Criteria

February 8, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7/18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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