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

This study has been completed.
Sponsor:
Information provided by:
Fertiligent
ClinicalTrials.gov Identifier:
NCT00745563
First received: August 30, 2008
Last updated: June 8, 2011
Last verified: December 2008
  Purpose

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:

  1. Placement of a diaphragm that contains raw spermatozoa or isolated improved spermatozoa in an appropriate liquid solution (Cup insemination, CI) upon the cervix.
  2. Spermatozoa injection (after improvement) through the vagina to the cervix (Intra-Cervical Insemination, ICI).
  3. 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.


Condition Intervention
Infertility
Device: Fertiligent

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Testing the Effect of Intra-uterine Slow-Release Insemination (SRI) on the Pregnancy Rate in Women Designated for Artificial Insemination

Resource links provided by NLM:


Further study details as provided by Fertiligent:

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 [ Time Frame: 2 weeks following procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Four weeks after insemination - US Viability scan [ Time Frame: 4 weeks following procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: October 2008
Study Completion Date: December 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Device: Fertiligent
Fertility treatment by using the EVIE - Slow Release Insemination method

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00745563

Locations
Israel
Carmel Medical Center
Haifa, Israel, 31048
Sponsors and Collaborators
Fertiligent
Investigators
Principal Investigator: Martha Dirnfeld, Prof. Carmel medical Center, Haifa Israel
  More Information

No publications provided

Responsible Party: Dr. Hanna Levy, Fertiligent
ClinicalTrials.gov Identifier: NCT00745563     History of Changes
Other Study ID Numbers: BRIDGE1 20/7/2008
Study First Received: August 30, 2008
Last Updated: June 8, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Fertiligent:
infertility
insemination
slow release

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 22, 2014