Proposed Research Protocol For Male Infertility

HaEmek Medical Center, Israel

Status: Unknown

Conditions: Male Infertility

Treatments: Procedure: Male Infertility Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT01255397

MF-001

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 30 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Male Infertility Protocol

Experimental group

Treatment:

Procedure: Male Infertility Protocol