Proposed Research Protocol For Male Infertility

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified December 2010 by HaEmek Medical Center, Israel.
Recruitment status was: Not yet recruiting

Sponsor:

Information provided by:

HaEmek Medical Center, Israel

ClinicalTrials.gov Identifier:

NCT01255397

First received: December 6, 2010

Last updated: NA

Last verified: December 2010

History: No changes posted

Purpose

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.

Condition	Intervention
Male Infertility	Procedure: Male Infertility Protocol


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Proposed Research Protocol For Male Infertility

Resource links provided by NLM:

Genetics Home Reference related topics: CATSPER1-related nonsyndromic male infertility Y chromosome infertility sensorineural deafness and male infertility

MedlinePlus related topics: Infertility Male Infertility

U.S. FDA Resources

Further study details as provided by HaEmek Medical Center, Israel:


Estimated Enrollment:	50
Study Start Date:	January 2011

Arms	Assigned Interventions
Experimental: Male Infertility Protocol	Procedure: Male Infertility Protocol 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.

Arms

Assigned Interventions

Experimental: Male Infertility Protocol

Procedure: Male Infertility Protocol

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.
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.

Eligibility


Ages Eligible for Study:	18 Years to 30 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided

More Information


Responsible Party:	Dr. Amir Weiss, HaEmek Medical Center
ClinicalTrials.gov Identifier:	NCT01255397 History of Changes
Other Study ID Numbers:	MF-001
Study First Received:	December 6, 2010
Last Updated:	December 6, 2010

Keywords provided by HaEmek Medical Center, Israel:


male infertility natural cycle IVF in-vitro fertilization intrauterine inseminatio

Additional relevant MeSH terms:


Infertility Infertility, Male Genital Diseases, Male Genital Diseases, Female

ClinicalTrials.gov processed this record on September 21, 2017

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