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

NCT00745563 | Completed DMC

• 1 other identifier: BRIDGE1 20/7/2008
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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:

• 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.

Conditions

Infertility

Keywords

infertility; insemination; slow release

Outcome Measures

Primary Outcomes (1)

• 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

  2 weeks following procedure

Secondary Outcomes (1)

• Four weeks after insemination - US Viability scan

  4 weeks following procedure

Study Arms (1)

A

EXPERIMENTAL

Device: Fertiligent

Interventions

Fertiligent DEVICE

Fertility treatment by using the EVIE - Slow Release Insemination method

A

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fertiligent: lead

Study Sites (1)

Carmel Medical Center

Haifa, 31048, Israel

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Martha Dirnfeld, Prof.

  Carmel medical Center, Haifa Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 30, 2008
• First Posted: September 3, 2008
• Study Start: October 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: December 1, 2009
• Last Updated: June 9, 2011

Record last verified: 2008-12

Locations

IL (1)