Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2011-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Male Infertility Protocol
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
30 Years
FEMALE
Yes
Sponsors
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HaEmek Medical Center, Israel
OTHER
Responsible Party
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HaEmek Medical Center
Other Identifiers
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MF-001
Identifier Type: -
Identifier Source: org_study_id