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Reproduction & Fertility Jan 2022To summarize the currently available phase I and II clinical trials of the effects of nonoxynol-9 (N-9) on human sperm structure and functions. (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
To summarize the currently available phase I and II clinical trials of the effects of nonoxynol-9 (N-9) on human sperm structure and functions.
METHODS
A systematic review and meta-analysis aiming to evaluate the spermicidal activity of N-9 on motility, was conducted in PubMed, EMBASE, and Cochrane databases by 10 March 2021. The counted numbers of progressive motile (PR) sperm in cervical mucus and the vanguard sperm penetration distances were analyzed. Other effects on sperm structures and physiological activities were reviewed as well.
RESULTS
In the pooled results, percentages or counted numbers of PR sperm decreased after the treatment of N-9. Vanguard sperm penetration distance was shortened in treated groups. N-9 has been confirmed to damage the structures of sperm, as well as other organelles like acrosome and mitochondria. The physiological activities such as generation of reactive oxygen species, superoxide dismutase activity, acrosin activity, and hemizona binding were all inhibited in the reviewed studies.
CONCLUSIONS
N-9 has several impacts on sperm owing to its potency in reducing sperm motility and cervical mucus penetration, as well as other functional competencies.
LAY SUMMARY
Nonoxynol-9 (N-9) has been used worldwide as a spermicide to kill sperm for more than 60 years but can cause side effects including vaginal irritation and can increase the rate of contraceptive failure. A detailed analysis of published literature aiming to evaluate the spermicidal activity of N-9 on sperm was carried out. In the pooled results, N-9 reduced the number of active sperm and the distance they traveled. It also caused damage to the structures of sperm and to the way the sperm acted and interacted with the egg. In conclusion, N-9 impacts on sperm in a number of ways that lead to sperm death and dysfunction.
Topics: Female; Humans; Male; Nonoxynol; Semen; Sperm Motility; Spermatocidal Agents; Spermatozoa
PubMed: 35350652
DOI: 10.1530/RAF-21-0024 -
The Cochrane Database of Systematic... Mar 2014Vasectomy is an increasingly popular and effective family planning method. A variety of vasectomy techniques are used worldwide, including vas occlusion techniques... (Review)
Review
BACKGROUND
Vasectomy is an increasingly popular and effective family planning method. A variety of vasectomy techniques are used worldwide, including vas occlusion techniques (excision and ligation, thermal or electrocautery, and mechanical and chemical occlusion methods), as well as vasectomy with vas irrigation or with fascial interposition. Vasectomy guidelines largely rely on information from observational studies. Ideally, the choice of vasectomy techniques should be based on the evidence from randomized controlled trials (RCTs).
OBJECTIVES
The objective of this review was to compare the effectiveness, safety, acceptability and costs of vasectomy techniques for male sterilization.
SEARCH METHODS
In February 2014, we updated the searches of CENTRAL, MEDLINE, POPLINE and LILACS. We looked for recent clinical trials in ClinicalTrials.gov and the International Clinical Trials Registry Platform. Previous searches also included EMBASE. For the initial review, we searched the reference lists of relevant articles and book chapters.
SELECTION CRITERIA
We included RCTs comparing vasectomy techniques, which could include suture ligature, surgical clips, thermal or electrocautery, chemical occlusion, vas plugs, vas excision, open-ended vas, fascial interposition, or vas irrigation.
DATA COLLECTION AND ANALYSIS
We assessed all titles and abstracts located in the literature searches. Two reviewers independently extracted data from articles identified for inclusion. Outcome measures include contraceptive efficacy, safety, discontinuation, and acceptability. Peto odds ratios (OR) with 95% confidence intervals (CI) were used for dichotomous outcomes, such as azoospermia. The mean difference (MD) was used for the continuous variable of operating time.
MAIN RESULTS
Six studies met the inclusion criteria. One trial compared vas occlusion with clips versus a conventional vasectomy technique. No difference was found in failure to reach azoospermia (no sperm detected). Three trials examined vasectomy with vas irrigation. Two studies looked at irrigation with water versus no irrigation, while one examined irrigation with water versus the spermicide euflavine. None found a difference between the groups for time to azoospermia. However, one trial reported that the median number of ejaculations to azoospermia was lower in the euflavine group compared to the water irrigation group. One high-quality trial compared vasectomy with fascial interposition versus vasectomy without fascial interposition. The fascial interposition group was less likely to have vasectomy failure. Fascial interposition had more surgical difficulties, but the groups were similar in side effects. Lastly, one trial found that an intra-vas was less likely to produce azoospermia than was no-scalpel vasectomy. More men were satisfied with the intra-vas device, however.
AUTHORS' CONCLUSIONS
For vas occlusion with clips or vasectomy with vas irrigation, no conclusions can be made as those studies were of low quality and underpowered. Fascial interposition reduced vasectomy failure. An intra-vas device was less effective in reducing sperm count than was no-scalpel vasectomy. RCTs examining other vasectomy techniques were not available. More and better quality research is needed to examine vasectomy techniques.
Topics: Aminoacridines; Humans; Male; Oligospermia; Randomized Controlled Trials as Topic; Spermatocidal Agents; Surgical Instruments; Therapeutic Irrigation; Vas Deferens; Vasectomy
PubMed: 24683020
DOI: 10.1002/14651858.CD003991.pub4 -
The Cochrane Database of Systematic... 2001The diaphragm is usually used with a spermicide. However, some practitioners have suggested that spermicides offer no additional contraceptive protection and have... (Review)
Review
BACKGROUND
The diaphragm is usually used with a spermicide. However, some practitioners have suggested that spermicides offer no additional contraceptive protection and have advocated alternative guidelines for the use of diaphragms.
OBJECTIVES
The objective of this review was to compare the effectiveness, safety and acceptability of the diaphragm with and without spermicide.
SEARCH STRATEGY
We searched MEDLINE, EMBASE, POPLINE, CINAHL, the Cochrane Controlled Trials Register, and reference lists of relevant articles. In addition, we contacted experts in the field to identify unpublished studies.
SELECTION CRITERIA
Randomized controlled trials comparing women of reproductive age using the diaphragm with and without spermicide as the sole contraceptive method that reported clinical outcomes.
DATA COLLECTION AND ANALYSIS
Two reviewers independently extracted data on outcomes and trial characteristics and any discrepancies were resolved by consensus or by consultation with the third reviewer. The results of the one identified study are presented descriptively.
MAIN RESULTS
We identified only one study. No significant difference was found in the pregnancy rates (with typical use or consistent use) or discontinuation rates between the diaphragm-with-spermicide and diaphragm-without-spermicide groups. There was a trend towards higher pregnancy rates in the diaphragm-without-spermicide group. However, this study failed to recruit the planned number of participants and was consequently underpowered.
REVIEWER'S CONCLUSIONS
As only one underpowered study was identified, we cannot distinguish between the contraceptive effectiveness of the diaphragm with and without spermicide. We cannot draw any conclusion at this point, further research is needed.
Topics: Contraception; Contraceptive Devices, Female; Female; Humans; Pregnancy; Randomized Controlled Trials as Topic; Spermatocidal Agents
PubMed: 11406025
DOI: 10.1002/14651858.CD002031 -
BMJ Sexual & Reproductive Health Jul 2021Our primary objective was to evaluate whether new types of single-size diaphragms or cervical caps differ in prevention of pregnancy compared with older types of... (Review)
Review
INTRODUCTION
Our primary objective was to evaluate whether new types of single-size diaphragms or cervical caps differ in prevention of pregnancy compared with older types of diaphragms, and whether different types of gels differ in their ability to prevent pregnancy. A secondary aim was to evaluate method discontinuation and complications.
METHODS
A comprehensive search was conducted in PubMed, Embase and the Cochrane Library. The certainty of evidence was assessed according to the GRADE system.
RESULTS
Four randomised controlled studies were included in the assessment. When comparing the new and old types of female barrier contraceptives the 6-month pregnancy rate varied between 11%-15% and 8%-12%, respectively. More women reported inability to insert or remove the FemCap device (1.1%) compared with the Ortho All-Flex diaphragm (0%) (p<0.0306). Urinary tract infections were lower when using the single-size Caya, a difference of -6.4% (95% CI -8.9 to -4.09) compared with the Ortho All-Flex diaphragm. The 6-month pregnancy rate for acid-buffering gel and spermicidal nonoxynol-9 gel varied between 10% and 12%. The discontinuation rate was lower in women who used acid-buffering gel compared with nonoxynol-9 gel (risk ratio (RR) 0.77, 95% CI 0.68 to 0.97).
CONCLUSIONS
Pregnancy rates were generally high in women using female barrier contraceptives. There was no difference in the efficacy for pregnancy prevention between the new types of diaphragms and cervical caps and the older diaphragms. The new types of diaphragms and cervical caps resulted in fewer urinary tract infections. Acid-buffering gels did not differ from spermicidal nonoxynol-9 gels regarding pregnancies but seemed to be better tolerated.
Topics: Contraception; Contraceptive Devices, Female; Diaphragm; Female; Gels; Humans; Pregnancy; Spermatocidal Agents
PubMed: 32868337
DOI: 10.1136/bmjsrh-2020-200632 -
The Cochrane Database of Systematic... 2002The contraceptive vaginal sponge was developed as an alternative to the contraceptive diaphragm. The sponge, made of polyurethane impregnated with nonoxynol-9 (1g),... (Comparative Study)
Comparative Study Review
BACKGROUND
The contraceptive vaginal sponge was developed as an alternative to the contraceptive diaphragm. The sponge, made of polyurethane impregnated with nonoxynol-9 (1g), releases 125 mg of the spermicide over 24 h of use. Unlike the diaphragm, the sponge can be used for more than one coital act within 24 h without the insertion of additional spermicide, and the sponge does not require fitting or a prescription from a physician. How the sponge compares with the diaphragm in terms of efficacy and continuation is not clear.
OBJECTIVES
To compare the efficacy and continuation rates of the sponge compared with the diaphragm (used with nonoxynol-9 as a spermicide). Our a priori hypothesis was that the sponge would have a higher failure rate and higher discontinuation rates than the diaphragm.
SEARCH STRATEGY
We searched the computerized databases MEDLINE, EMBASE, Popline, LILACS, and the Cochrane Controlled Trials Register. In addition, we searched the reference lists of all potentially relevant articles and book chapters. We also contacted investigators involved with both trials identified to seek other published or unpublished trials.
SELECTION CRITERIA
We included randomized controlled trials comparing the vaginal contraceptive sponge (Today; Collatex) with any diaphragm used with nonoxynol-9 to prevent pregnancy.
DATA COLLECTION AND ANALYSIS
We examined the studies identified through the literature searches for possible inclusion and evaluated their methodological quality using the Cochrane guidelines. We contacted an author involved with both published trials for supplementary information about randomization and allocation concealment. We entered data into RevMan 4.1 and calculated Peto odds ratios for overall pregnancy and 12-month discontinuation using numbers of women as the denominator. We also abstracted 12-month cumulative life-table ratios for these same outcomes, but were unable to aggregate these data.
MAIN RESULTS
The sponge was statistically significantly less effective in both trials in preventing overall pregnancy than was the diaphragm. The 12-month cumulative life-table termination rates per 100 women for overall pregnancy were 17.4 for the sponge versus 12.8 for the diaphragm in the larger U.S. trial and 24.5 for the sponge and 10.9 for the diaphragm in the U.K. trial. Similarly, discontinuation rates at 12 months were higher with the sponge than with the diaphragm (odds ratio 1.3; 95% CI 1.1-1.6). Allergic-type reactions were more common with the sponge in both trials, although the frequency of discontinuation for discomfort differed in the two trials.
REVIEWER'S CONCLUSIONS
The sponge was less effective than the diaphragm in preventing pregnancy. Discontinuation rates were higher at 12 months as well. Other randomized controlled trials will be needed to resolve the role of spermicides in preventing sexually transmitted infections or in causing adverse effects.
Topics: Contraceptive Devices, Female; Female; Humans; Nonoxynol; Randomized Controlled Trials as Topic; Spermatocidal Agents
PubMed: 12137678
DOI: 10.1002/14651858.CD003172 -
The Cochrane Database of Systematic... 2002There is a need for female-controlled methods of HIV prevention. Vaginal microbicides, substances inserted into the vagina to prevent women acquiring HIV and sexually... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
There is a need for female-controlled methods of HIV prevention. Vaginal microbicides, substances inserted into the vagina to prevent women acquiring HIV and sexually transmitted infections (STIs) from men, could be useful in this regard. One potential vaginal microbicide is the widely used spermicide, nonoxynol-9 (N-9).
OBJECTIVES
To determine the safety and effectiveness of N-9 in preventing vaginal acquisition of HIV infection by women from men.
SEARCH STRATEGY
Extensive searches of electronic databases, conference abstracts, reference lists of relevant studies and contact with experts and funders.
SELECTION CRITERIA
Randomised controlled trials meeting pre-determined quality criteria with HIV infection as the outcome.
DATA COLLECTION AND ANALYSIS
Data were extracted by one reviewer and checked by the another. Any discrepancies were adjudicated by a third reviewer.
MAIN RESULTS
Five trials were included in the review and four contributed to a meta-analysis. Overall, the risk of HIV infection was not statistically significantly different among women receiving N-9 (relative risk [RR] 1.12, 95% CI 0.88-1.42; p=0.4). The risk of genital lesions was statistically significantly greater among women receiving N-9 (RR 1.18, 95%CI 1.02-1.36; p=0.02).
REVIEWER'S CONCLUSIONS
There is no evidence that nonoxynol-9 protects against vaginal acquisition of HIV infection by women from men. There is evidence that it may do harm by increasing the frequency of genital lesions.
Topics: Coitus; Female; HIV Infections; Humans; Male; Nonoxynol; Randomized Controlled Trials as Topic; Spermatocidal Agents
PubMed: 12519622
DOI: 10.1002/14651858.CD003936