search
Back to results

Proposed Research Protocol For Male Infertility

Primary Purpose

Male Infertility

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Male Infertility Protocol
Sponsored by
HaEmek Medical Center, Israel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Male Infertility focused on measuring male infertility, natural cycle IVF, in-vitro fertilization, intrauterine inseminatio

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Couples with "pure" male factor infertility of six months or more, defined as not pregnant in spite of being desirous of pregnancy for at least six months with normal sexual activity and no birth control. Primary and Secondary infertility included.
  2. Abnormality of any one of the sperm parameters according to WHO or Kruger for concentration, motility or morphology.
  3. Women aged 18 to 30 with a BMI between 18 and 30
  4. Women who testify that they are healthy with regular menstrual cycles between 25-35 days per cycle.

Exclusion Criteria:

  1. Uterine fibroids or ovarian cysts or tumors or suspected hydrosalpinx on US on prior fertility workup. Paraovarian simple cysts, OK.
  2. Prior PID, abdominal or pelvic surgery or abnormal HSG if done.
  3. Known allergy to medications used in protocol
  4. Diagnosed or suspected genetic or psychiatric disease in either patient.
  5. Azoospermia
  6. Female partner with a history of infertility with another partner
  7. Elevated FSH (over 10 units/L) in female partner if done.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Male Infertility Protocol

    Arm Description

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    December 6, 2010
    Last Updated
    December 6, 2010
    Sponsor
    HaEmek Medical Center, Israel
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01255397
    Brief Title
    Proposed Research Protocol For Male Infertility
    Official Title
    Proposed Research Protocol For Male Infertility
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2010
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2011 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    HaEmek Medical Center, Israel

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this experiment is to test the feasibility of a minimally interventionist protocol for young couples with male factor infertility, which addresses the cause of infertility for these couples which is the inability of the sperm to fertilize the egg.Ultrasound monitoring of natural follicular development utilizing rFSH, GnRH antagonist and rHCG only for the final maturation. Single follicle aspiration and IUI or IVF/ICSI based on sperm charcteristics on the day of fertilization. Fertilized eggs transfered to the uterus on the same day as the aspiration.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Male Infertility
    Keywords
    male infertility, natural cycle IVF, in-vitro fertilization, intrauterine inseminatio

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Male Infertility Protocol
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    Male Infertility Protocol
    Intervention Description
    Healthy women with a regular cycle between 28 and 35 days. For the man, an abnormal sperm exam. Daily US examinations from day 8 of the menstrual cycle. Excluding weekends. When the leading follicle is 14 mm she will be given 100 units puregon and orgalutran,once daily until the leading follicle is at least 16 mm at which point she will be given ovitrelle at 21:00. 35 hours after Ovitrelle at 8:00 the husband will present a sperm sample for analysis. A pelvic US will be done to the wife. If the follicle has collapsed than IUI will be performed It the total motile sperm count is above 5 million sperm/ml then IUI will be done If the total motile sperm count is below 5 million and the follicle has not collapsed, proceed to oocyte aspiration and ICSI 6) ICSI and embryo transfer performed on the same day. 7) Luteal support: Endometrin 100 mg twice a day following IUI\ET until 6 weeks gestation Protocol can be repeated for up to 3 cycles per couple.

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Couples with "pure" male factor infertility of six months or more, defined as not pregnant in spite of being desirous of pregnancy for at least six months with normal sexual activity and no birth control. Primary and Secondary infertility included. Abnormality of any one of the sperm parameters according to WHO or Kruger for concentration, motility or morphology. Women aged 18 to 30 with a BMI between 18 and 30 Women who testify that they are healthy with regular menstrual cycles between 25-35 days per cycle. Exclusion Criteria: Uterine fibroids or ovarian cysts or tumors or suspected hydrosalpinx on US on prior fertility workup. Paraovarian simple cysts, OK. Prior PID, abdominal or pelvic surgery or abnormal HSG if done. Known allergy to medications used in protocol Diagnosed or suspected genetic or psychiatric disease in either patient. Azoospermia Female partner with a history of infertility with another partner Elevated FSH (over 10 units/L) in female partner if done.

    12. IPD Sharing Statement

    Learn more about this trial

    Proposed Research Protocol For Male Infertility

    We'll reach out to this number within 24 hrs