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Proposed Research Protocol For Male Infertility

NCT01255397 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2010-12-07

No results posted yet for this study

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.

Conditions

  • Male Infertility

Interventions

PROCEDURE

Male Infertility Protocol

1. Healthy women with a regular cycle between 28 and 35 days. For the man, an abnormal sperm exam. 2. Daily US examinations from day 8 of the menstrual cycle. Excluding weekends. 3. 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. 4. 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. 1. If the follicle has collapsed than IUI will be performed 2. It the total motile sperm count is above 5 million sperm/ml then IUI will be done 3. 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.

Sponsors & Collaborators

  • HaEmek Medical Center, Israel

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31

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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 NCT01255397 on ClinicalTrials.gov