Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202406866432721 Date of Registration: 05/06/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The in Vitro Effects of a Water-based Vaginal Lubricant on Sperm Parameters. A Randomized Controlled Study
Official scientific title The in Vitro Effects of a Water-based Vaginal Lubricant on Sperm Parameters. A Randomized Controlled Study
Brief summary describing the background and objectives of the trial Vagina lubricants are water, silicone, or oil-based products applied on the vulva, vagina and penis during penetrative sexual intercourse. Lubricants provide acute interim relief of discomfort or pain during sexual intercourse arising from vaginal dryness. Users of vaginal lubricant may experience irritation, burning and damaging effects to the vaginal and rectal tissue. Water-based lubricant may cause less irritation but has the worst effect on the mean sperm progressive motility, viability and sperm chromatin quality. These effects are due to the hyperosmolality of these lubricants compared to a healthy vaginal fluid. There are concerns on the safety of some commercially available over the counter vaginal lubricants on the vaginal microflora as well as on the sperm parameters. Therefore, it is imperative to guide couples trying to conceive in picking lubricants which are physiologically similar to the seminal, vaginal and cervical secretions in terms of PH and osmolality where necessary. The objective of this study is to determine in-vitro the effects of a water-based (pre-seed®) vaginal lubricant against control on the progressive sperm motility, morphology, and vitality.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-male
Purpose of the trial Education /Training
Anticipated trial start date 17/06/2024
Actual trial start date 01/07/2024
Anticipated date of last follow up 30/08/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
1052023 Health Research Ethic Committe, National Hospital Abuja
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Preseed vaginal lubricant 0.5ml of 10% v/v concentration of pre-seed vaginal lubricant 5 minutes, 30 minutes and 60 minutes exposure A two-step discontinuous density-gradient centrifugation method will be applied for sperm preparation. An equal volume of semen sample will be added to the density gradient media, PureCeption 40%/80% (CooperSurgical Inc, Trumbull, USA) in a 15ml conical tube and then centrifuged at 1200 revolutions for 10 minutes. The supernatant is decanted to get the sperm pellets which are then suspended in a sperm wash media, ORIGIO (CooperSurgical Inc, Trumbull, USA), and centrifuged again for another 5 to 10 minutes. The supernatant is decanted and 0.5ml of the pellets is placed in microcentrifuge tube to which 0.5ml of 10% v/v concentration of Pre-seed vaginal lubricant is added and incubated at 37 degree Celsius. After predefined periods of 5minutes, 30minutes and 60minutes of exposure to the lubricant, a slide is then prepared from the mixture after proper mixing and viewed to determine the sperm progressive motility. Morphology will be assessed after preparing a smear and stained using the Papanicolaou staining technique. For sperm Vitality, after predefined periods of 5 minutes, 30minutes and 60minutes of exposure to the lubricant, eosin and nigrosin stains will be added to a well-mixed 50-µl aliquot of the sperm and lubricant mixture and a slide will be prepared and air dried before viewing for sperm vitality. 40
Control Group Sperm wash medium 0.5ml of sperm wash medium 5 minutes, 30 minutes and 60 minutes exposure A two-step discontinuous density-gradient centrifugation method will be applied for sperm preparation. An equal volume of semen sample will be added to the density gradient media, PureCeption 40%/80% (CooperSurgical Inc, Trumbull, USA) in a 15ml conical tube and then centrifuged at 1200 revolutions for 10 minutes. The supernatant is decanted to get the sperm pellets which are then suspended in a sperm wash media, ORIGIO (CooperSurgical Inc, Trumbull, USA), and centrifuged again for another 5 to 10 minutes. The supernatant is decanted and 0.5ml of the pellets is placed in a microcentrifuge tube to which 0.5ml of the sperm wash medium is added and incubated at 37 degree Celsius. After predefined periods of 5 minutes, 30minutes and 60minutes of exposure to the sperm wash medium, a slide is then prepared from the mixture after proper mixing and viewed to determine the sperm progressive motility. Morphology will be assessed after preparing a smear and stained using the Papanicolaou staining technique. For sperm Vitality, after predefined periods of 5 minutes, 30minutes and 60minutes of exposure to the sperm wash medium, eosin and nigrosin stains will be added to a well-mixed 50-µl aliquot of the sperm and sperm wash medium mixture and a slide will be prepared and air dried before viewing for sperm vitality. 40 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Consenting male ≥ 18 to ≤ 55 years with proven normal semen parameters at baseline assessment. Sperm progressive motility of at least 30 (29-31%) WHO 5th centile Sperm vitality of at least 54 (50-56%) WHO 5th centile Sperm morphology of at least 4(3.9-4%) WHO 5th centile Patients younger than 18 or >55 years of age. Aspermia Oligozoospermia Hypospermia, Asthenozoospermia Necrozoospermia Teratozoospermia Samples not produced via masturbation Contaminated samples Patients who were on medication that may affect semen parameters Adult: 18 Year(s)-44 Year(s) 18 Year(s) 55 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 13/05/2024 Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Plot 132 Ali Muhammad Zarah Abuja 900211 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mean sperm progressive motility after exposure to Pre-seed vaginal lubricant and control At 5 minutes, 30 minutes and 60 minutes after exposure to Pre-seed vaginal lubricant and control
Secondary Outcome Sperm morphology after exposure to pre-seed vaginal lubricant and control At 5 minutes, 30 minutes and 60 minutes after exposure to pre-seed vaginal lubricant and control
Secondary Outcome Mean sperm vitality after exposure to pre-seed vaginal lubricant and control At 5 minutes, 30 minutes and 60 minutes after exposure to pre-seed vaginal lubricant and control
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Hospital Abuja Plot 132 Ali Muhammad Zarah Abuja 900211 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Federal government of Nigeria through the National Postgraduate Medical college of Nigeria residency training fund Km 26 Lagos-Badagry expressway Ijanikin Lagos 102004 Nigeria
Self Plot 132 Ali Muhammed Zarah Abuja 900211 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Unimke Agim Plot 132 Ali Muhammad Zarah Abuja 900211 Nigeria Self Sponsored
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Unimke Agim unimkeagimj@gmail.com +2348030411566 Plot 132 Ali Muhammed Zarah street, Department of Obstetrics and Gynecology, National Hospital Abuja, Nigeria
City Postal code Country Position/Affiliation
Abuja 900211 Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries Unimke Agim unimkeagimj@gmail.com +2348030411566 Plot 132 Ali Muhammed Zarah street, Department of Obstetrics and Gynecology, National Hospital Abuja, Nigeria
City Postal code Country Position/Affiliation
Abuja 900211 Nigeria Senior Registrar
Role Name Email Phone Street address
Scientific Enquiries Unimke Agim unimkeagimj@gmail.com +2348030411566 Plot 132 Ali Muhammed Zarah street, Department of Obstetrics and Gynecology, National Hospital Abuja, Nigeria
City Postal code Country Position/Affiliation
Abuja 900211 Nigeria Senior registrar
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the study will be available for sharing after deidentification. Informed Consent Form,Study Protocol 1 year Opened Access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information