AsthenozoospermiaNCT03463005
The Effect of Royal Vaginal Gel Compared to IUI Technique on Fertility Rate of Women With Low-fertility Husbands
A study testing Royal jelly and IUI in people with Asthenozoospermia, run by Gonabad University of Medical Sciences.
Trial summary
The present Pocock clinical trial study was conducted In the city of Mashhad in Iran between 2015 and 2016. The study inclusion criteria were men with low fertility of sperm motility<25% and total motility <50% (asthenozoospermia), no history of endocrine diseases, no diabetes men, no hormonal problems in their wives… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Asthenozoospermia
- What is being tested?
- Royal jelly and IUI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 10 Dec 2017
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Male-factor infertility (defined as total sperm motility<40% and sperm motility<20%)
- Normal hormonal profile in women
- Normal hysterosalpingography report
- Regular sexual relationships
Who cannot join
- Ovulation dysfunction
- History of sexually transmitted diseases in women and men
- Hormonal disorders in men and women
About this study
Official title: Male Infertility and Complementary Treatment
The present Pocock clinical trial study was conducted In the city of Mashhad in Iran between 2015 and 2016. The study inclusion criteria were men with low fertility of sperm motility<25% and total motility <50% (asthenozoospermia), no history of endocrine diseases, no diabetes men, no hormonal problems in their wives, and a healthy salpingography in their wives. The study subjects were voluntarily assigned to royal gel and IUI groups. In royal gel group, 5 grams of royal gel was used after menstruation and every other night before and after intercourse. IUI group received 75 units of FSH from the second day of the cycle. Then vaginal ultrasound was performed from the sixth day of menstrual cycle to determine the right size of follicle. 10000 units of HCG was administered when follicle diameter reached 16mm, and the study subject was prepared for IUI 32-36 hours later. Each subject alternately swapped groups following fertility failure.
Read the detailed description
After selection of subjects and obtaining their informed consents, the quality of royal gel was examined.
The quality of royal gel is determined by the amount of polyphenol it contains. Polyphenol in royal gel was assessed in the following stages: first, the sample was diluted with ethanol 50% to 1:10 ratio, and then, 100µl of this preparation was poured into a test tube, and 750µl of 1:10 diluted solution of FCR (Folin Ciocalteau Reagent) was added and left at room temperature for five minutes. Then, 750µl of sodium carbonate 6% solution was added to each tube, and after keeping these tubes in the dark for one hour, absorption was measured at 780nm wavelength. Negative control consisted of all reaction compounds, except the sample, for which, ethanol 50% was used instead. The sample concentration was determined using the gallic acid standard. By definition, the desirable quality of polyphenol in natural royal gel ranges from 0.15mg (minimum) to 0.75mg (maximum) in every 100 grams, and this was determined 0.5 mg for the sample used in the present study, indicating a good quality (15).
- Conditions
- Asthenozoospermia
- Being tested
- Royal jelly, IUI
- Medical subject headings
- Asthenozoospermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Royal jellyOther
Also called Complementary group
The study subjects in the Royal jelly group used 10 ml of the vaginal Royal jell few minutes before and few minutes after intercourse one day after the end of menstruation for two weeks.
IUIProcedure or surgery
Subjects in IUI group received 75 units of FSH from the second day of the cycle.
| Study group | Role | What they receive |
|---|---|---|
| Royal jelly | Experimental | The study subjects included healthy women who had husbands with male-factor infertility problems. Receives: Other: Royal jelly |
| IUI group | Active comparator | The study subjects included in IUI group were healthy women who had husbands with male-factor infertility problems. Receives: Procedure: IUI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of pregnancy
Occurrence of pregnancy be detected by B-HCG test
Measured: Three months after intervention
Secondary outcomes (1)
confirmation of pregnancy
Abdominal sonography to approve pregnancy and visit embryo sac.
Measured: Three months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start1 Jan 2016
- Primary completion20 Sep 2017
- Study completion10 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthenozoospermiaStudies 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
- Non-randomised
- Intervention model
- Crossover
- Model description
- The study subjects were voluntarily assigned to royal gel and IUI groups. In royal gel group, 5 grams of royal gel was used after menstruation and every other night before and after intercourse. IUI group received 75 units of FSH from the second day of the cycle.
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gonabad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Mashhad University of Medical Sciences
- Responsible party
- Principal investigator, Narjes Bahri, Gonabad University of Medical Sciences
- Investigators
- Tahereh Fathi Najafi, Instructor, Study director, Midwifery department, Islamic Azad Medical University, Mashhad branc, Mashhad, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463005
- Sponsor's protocol ID
- 921175
- Status last verified
- Mar 2018
- First submitted
- 18 Feb 2018
- Last updated
- 13 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Male Infertility and Complementary Treatment
- ClinicalTrials.gov ID
- NCT03463005
- Acronym / sponsor ID
- 921175
- Conditions
- Asthenozoospermia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Gonabad University of Medical SciencesUniversity, hospital or other
- Collaborators
- Mashhad University of Medical Sciences
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 20 Sep 2017 (actual)
- Study completion
- 10 Dec 2017 (actual)
- First posted
- 13 Mar 2018 (actual)
- 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 present Pocock clinical trial study was conducted In the city of Mashhad in Iran between 2015 and 2016. The study inclusion criteria were men with low fertility of sperm motility<25% and total motility <50% (asthenozoospermia), no history of endocrine diseases, no diabetes men, no hormonal problems in their wives, and a healthy salpingography in their wives. The study subjects were voluntarily assigned to royal gel and IUI groups. In royal gel group, 5 grams of royal gel was used after menstruation and every other night before and after intercourse. IUI group received 75 units of FSH from the second day of the cycle. Then vaginal ultrasound was performed from the sixth day of menstrual cycle to determine the right size of follicle. 10000 units of HCG was administered when follicle diameter reached 16mm, and the study subject was prepared for IUI 32-36 hours later. Each subject alternately swapped groups following fertility failure.
Detailed description
After selection of subjects and obtaining their informed consents, the quality of royal gel was examined.
The quality of royal gel is determined by the amount of polyphenol it contains. Polyphenol in royal gel was assessed in the following stages: first, the sample was diluted with ethanol 50% to 1:10 ratio, and then, 100µl of this preparation was poured into a test tube, and 750µl of 1:10 diluted solution of FCR (Folin Ciocalteau Reagent) was added and left at room temperature for five minutes. Then, 750µl of sodium carbonate 6% solution was added to each tube, and after keeping these tubes in the dark for one hour, absorption was measured at 780nm wavelength. Negative control consisted of all reaction compounds, except the sample, for which, ethanol 50% was used instead. The sample concentration was determined using the gallic acid standard. By definition, the desirable quality of polyphenol in natural royal gel ranges from 0.15mg (minimum) to 0.75mg (maximum) in every 100 grams, and this was determined 0.5 mg for the sample used in the present study, indicating a good quality (15).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study subjects were voluntarily assigned to royal gel and IUI groups. In royal gel group, 5 grams of royal gel was used after menstruation and every other night before and after intercourse. IUI group received 75 units of FSH from the second day of the cycle.
| Arm | Type | Receives |
|---|---|---|
| Royal jelly | Experimental | Other: Royal jellyThe study subjects included healthy women who had husbands with male-factor infertility problems. |
| IUI group | Active comparator | Procedure: IUIThe study subjects included in IUI group were healthy women who had husbands with male-factor infertility problems. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Male-factor infertility (defined as total sperm motility<40% and sperm motility<20%)
- Normal hormonal profile in women
- Normal hysterosalpingography report
- Regular sexual relationships
Key exclusion criteria (3 listed)
- Ovulation dysfunction
- History of sexually transmitted diseases in women and men
- Hormonal disorders in men and women
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 |
|---|---|---|
| Royal jellyAlso: Complementary groupThe study subjects in the Royal jelly group used 10 ml of the vaginal Royal jell few minutes before and few minutes after intercourse one day after the end of menstruation for two weeks. | Other | Royal jelly |
| IUISubjects in IUI group received 75 units of FSH from the second day of the cycle. | Procedure or surgery | IUI group |
Primary outcome
Occurrence of pregnancy
Time frame: Three months after intervention
Occurrence of pregnancy be detected by B-HCG test
1 secondary outcome
confirmation of pregnancy
Time frame: Three months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2018.
- Individual participant dataSharing planned: No
Related trials for Asthenozoospermia
Not yet recruitingPhase 2
A Study to Evaluate the Safety and Efficacy of Multiple Dose of STSP-0902 in Patients With Oligozoospermia and/or Asthenozoospermia.
Oligozoospermia and/or Asthenozoospermia
RecruitingObservational study
Efficacy and Safety of a New Sperm Capacitation Method
Reproductive Issues, Male Infertility
RecruitingPhase 2/3
PKB171 Against Placebo in Couples With Mild Male Factor Infertility
Infertility Due to Azoospermia
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Effect of Daily Intake of Gazpacho on Semen Quality and Oxidative Stress
Male Infertility, Oxidative Stress
Recruiting
Probiotics on Sperm Quality in Male Infertility Patients
Male Infertility, Oligozoospermia
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.
Tahereh Fathi Najafi, Instructor study director
Midwifery department, Islamic Azad Medical University, Mashhad branc, Mashhad, Iran
Questions about this trial
What is this clinical trial studying?
A study testing Royal jelly and IUI in people with Asthenozoospermia, run by Gonabad University of Medical Sciences.
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 3 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: finished, as of the sponsor's last update on 13 Mar 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Occurrence of pregnancy (time frame: Three months after intervention). It is what the study was designed to measure, not a finding.
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 13 Mar 2018.