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

NCT00745563 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2011-06-09

No results posted yet for this study

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:

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.

Conditions

Interventions

DEVICE

Fertiligent

Fertility treatment by using the EVIE - Slow Release Insemination method

Sponsors & Collaborators

  • Fertiligent

    lead INDUSTRY

Principal Investigators

  • Martha Dirnfeld, Prof. · Carmel medical Center, Haifa Israel

Study Design

Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-06-30
Completion
2009-12-31

Countries

  • Israel

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00745563 on ClinicalTrials.gov