Male InfertilityNCT01255397
Proposed Research Protocol For Male Infertility
A study testing Male Infertility Protocol in people with Male Infertility, run by HaEmek Medical Center, Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Male Infertility
- What is being tested?
- Male Infertility Protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
- Being tested
- Male Infertility Protocol
- Keywords
- male infertility, natural cycle IVF, in-vitro fertilization, intrauterine inseminatio
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Male Infertility ProtocolProcedure or surgery
- 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
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Male Infertility Protocol | Experimental | Not described Receives: Procedure: Male Infertility Protocol |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2010 (estimated)
- Study startJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01255397
- Sponsor's protocol ID
- MF-001
- Status last verified
- Dec 2010
- First submitted
- 6 Dec 2010
- Last updated
- 7 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proposed Research Protocol For Male Infertility
- ClinicalTrials.gov ID
- NCT01255397
- Acronym / sponsor ID
- MF-001
- Conditions
- Male Infertility
- Keywords
- male infertility, natural cycle IVF, in-vitro fertilization, intrauterine inseminatio
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Jan 2011
- First posted
- 7 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Male Infertility Protocol | Experimental | Procedure: Male Infertility Protocol |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Male Infertility Protocol1. 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. | Procedure or surgery | Male Infertility Protocol |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Male Infertility Protocol in people with Male Infertility, run by HaEmek Medical Center, Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2010.