search
Back to results

Effects of Intra-uterine Slow-Release Insemination on Pregnancy Rate in Women Designated for Artificial Insemination

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Fertiligent
Sponsored by
Fertiligent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring infertility, insemination, slow release

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Primary or secondary infertility designated for IUI treatment.
  • Age of candidates: 20-40 years.
  • Normal uterus x-ray.
  • Women suffering from infertility on a background of non-ovulation.
  • Infertility on a background of male problems (over 10 million of motile sperm cells per sample).
  • Infertility on background of unexplained problem
  • Same sex patients / single patient
  • Written informed consent

Exclusion Criteria:

  • Woman under the age of 20 or over the age of 40 years.
  • Female infertility on mechanical background (different blockages, irregular uterus).
  • Infertility on male background of medium to very low level of spermatozoa - less than 10 million motile sperm cells per sample.
  • Men and women who are opposed to the random spermatozoa insemination method.
  • Participants who are not willing to sign the Consent Form.

Sites / Locations

  • Carmel Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

Outcomes

Primary Outcome Measures

Accumulation of 50 cycles of SRI- slow release insemination (study group) in addition to 50 cycles of regular IUI (control group). Two weeks after insemination Beta hCG test

Secondary Outcome Measures

Four weeks after insemination - US Viability scan

Full Information

First Posted
August 30, 2008
Last Updated
June 8, 2011
Sponsor
Fertiligent
search

1. Study Identification

Unique Protocol Identification Number
NCT00745563
Brief Title
Effects of Intra-uterine Slow-Release Insemination on Pregnancy Rate in Women Designated for Artificial Insemination
Official Title
Testing the Effect of Intra-uterine Slow-Release Insemination (SRI) on the Pregnancy Rate in Women Designated for Artificial Insemination
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Fertiligent

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A couple that does not achieve pregnancy though regular attempts for a year are defined infertile couple. This condition is caused by faulty functioning of the reproduction system of the husband or wife or both. If there are no organic defects and there is no definite injury to the reproductive system (ova or spermatozoa), the specialist doctor generally decides to put the couple into a fertility treatment program. Artificial insemination is one of the important ways of achieving pregnancy. Three common methods of artificial insemination: Placement of a diaphragm that contains raw spermatozoa or isolated improved spermatozoa in an appropriate liquid solution (Cup insemination, CI) upon the cervix. Spermatozoa injection (after improvement) through the vagina to the cervix (Intra-Cervical Insemination, ICI). Spermatozoa injection (after improvement) directly into the uterus (IUI-Intra-Uterine Insemination). The EVIE - Slow Release Insemination method: The slow release insemination is utilizing a Grasby type MS16 pump for 3 hours. The release rate for motile spermatozoa is 50X103 per minute. Advantages: Very close approximation of the natural procedure in which the spermatozoa arrive to the fertilization site over a long period. An extended "window of opportunities" for meeting between the ovum and spermatozoa will be longer. There is no loss of spermatozoa due to leaking as sometimes happens with single-time injection practiced in the IUI method. Primary Endpoint: Accumulation of 50 cycles of SRI- slow release insemination (study group) in addition to 50 cycles of regular IUI (control group). Two weeks after insemination Beta hCG test Secondary Endpoints: Four weeks after insemination - US Viability scan Procedure: Subjects will be women with fertility difficulties who are designated for IUI treatment. 100 insemination cycles will be conducted. (50 regular IUI and 50 EVIE-SRI). Subjects that were treated with the IUI method and who does not become pregnant will then be treated with the EVIE-Slow Release method and vice versa.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
infertility, insemination, slow release

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Fertiligent
Intervention Description
Fertility treatment by using the EVIE - Slow Release Insemination method
Primary Outcome Measure Information:
Title
Accumulation of 50 cycles of SRI- slow release insemination (study group) in addition to 50 cycles of regular IUI (control group). Two weeks after insemination Beta hCG test
Time Frame
2 weeks following procedure
Secondary Outcome Measure Information:
Title
Four weeks after insemination - US Viability scan
Time Frame
4 weeks following procedure

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary or secondary infertility designated for IUI treatment. Age of candidates: 20-40 years. Normal uterus x-ray. Women suffering from infertility on a background of non-ovulation. Infertility on a background of male problems (over 10 million of motile sperm cells per sample). Infertility on background of unexplained problem Same sex patients / single patient Written informed consent Exclusion Criteria: Woman under the age of 20 or over the age of 40 years. Female infertility on mechanical background (different blockages, irregular uterus). Infertility on male background of medium to very low level of spermatozoa - less than 10 million motile sperm cells per sample. Men and women who are opposed to the random spermatozoa insemination method. Participants who are not willing to sign the Consent Form.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martha Dirnfeld, Prof.
Organizational Affiliation
Carmel medical Center, Haifa Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carmel Medical Center
City
Haifa
ZIP/Postal Code
31048
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

Effects of Intra-uterine Slow-Release Insemination on Pregnancy Rate in Women Designated for Artificial Insemination

We'll reach out to this number within 24 hrs