Proposed Research Protocol For Male Infertility
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ClinicalTrials.gov Identifier: NCT01255397 |
Recruitment Status
: Unknown
Verified December 2010 by HaEmek Medical Center, Israel.
Recruitment status was: Not yet recruiting
First Posted
: December 7, 2010
Last Update Posted
: December 7, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Male Infertility | Procedure: Male Infertility Protocol | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Proposed Research Protocol For Male Infertility |
Study Start Date : | January 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: Male Infertility Protocol |
Procedure: Male Infertility Protocol
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. |

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Ages Eligible for Study: | 18 Years to 30 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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.
Responsible Party: | Dr. Amir Weiss, HaEmek Medical Center |
ClinicalTrials.gov Identifier: | NCT01255397 History of Changes |
Other Study ID Numbers: |
MF-001 |
First Posted: | December 7, 2010 Key Record Dates |
Last Update Posted: | December 7, 2010 |
Last Verified: | December 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 |