POST-VASECTOMY RECANALISATION UNDER MAGNIFICATION AND EVALUATION OF THE USE OF AN ETHICAL INDIGENOUS PRODUCT AFTER OPERATION ( A Controlled Trial )
*(Mrs.) I. Saha, **N. Polle and ***A. C. Ganguly
*M S., M.Ch. **M B.B S. **,*Professor and Head from the Dept. of Plastic Surgery, Medical College Calcutta.
Calcutta Medical Journal, Vol. 83, No. 3 & 4, March-April, ’86
NECESSITY FOR RECANALISATION
Vasectomy as a measure of Family. manning is widely used in our country because of its ease, safety, and complete success. Very often a large number of vasectomized husbands come back with a request for recanalization. The most common cause for this is the unfortunate loss of all the children and the parents become childless. Occasionally the man may come for recanalization due to the demise of his first wife in middle age and his desire to marry again. However, he may not get a woman to marry him unless she is assured of motherhood. It is becoming increasingly difficult for husbands to accept vasectomy as a measure of Family Planning unless they are given full assurance that recanalization could be done successfully in the future in case necessity and that vasectomy is reversible. As such the question of recanalization in the Family Planning Programme has assumed as much importance as vasectomy, if not more.
Things do not stop with successful recanalization. Proper spermatogenesis and good quality and quantity of semen must be achieved after obstruction and suppression of semen since years after vasectomy, was done. This aspect requires particular attention for the realization of the fruits of recanalization so as to restore normal reproductive life.
For this study, we selected an Ayurvedic drug to assess whether it is beneficial after recanalization in achieving normal quality and quantity of semen.
A short review of literature on the drug
Joshi (1965) used the drug with benefits in Sexual Debility, Functional Impotence, and Premature Ejaculations. Gupta & Saluja (1975) in a case report of oligospermia observed that the drug increased sperm count, percentage of motile sperms and the quantity of semen. Shelat (1977) in a Controlled Trial reported the beneficial effects of the drug in increasing sperm count in cases of oligospermia from 10-30 mIns/ ml to 30-60 mins./ml. and an increase in motility from 40% and less to 50%-60%. Kamlesh Kumar (1978) observed the usefulness of the drug in the management of sexual Disorders: Oligospermia, Sperms of poor motility, Premature Ejaculations, Night Emissions and Sex Debility. Bhalerao (1979, 1980) in a Controlled Trial found the product useful in the management of Male Infertility associated with oligospermia. Jagadisan (1981) used the drug in men in cases of Couple Infertility with success. Panda et al (1982) in a Double-Blind Study found it beneficial in the management of Male Infertility.
Composition
Each tablet contains : Jeevanti (Leptadenia Reticulata) 56 mg. ; Suddha Kachura (Detoxicated nuxvomica) 30 mg. ; Asan (Withania Somnifera – Ashwagandha) 15 mg ; Vacha (Acorns Calamus) 7.5 mg. ; Akalakara (Anocyclus Pyrethrum) 7.5 mg. ; (Sukhed ver Santalum album) 7.5 mg. ; Jaifal ( Myristica Fragrans ) 4.5 mg ; Javantri (Myristica Fragrans-arillus) 3 mg. Kamboji (Breynia Patens) 56 mg. ; Kauncha Beej (Mucuna Pruriene) 30 mg. ; Samudra-sosh Beej (Argyria Speciosa) 15 mg ; Var-dhara Beej (Rourea Santaloides) 15 mg. Var-dhara Mool (Rourea Santaloides-root) 15mg Laving (Caryophyllus aromaticus) 7.5 mg. ; Piper (Piper Longum) 7.5 mg. ; Mari (Piper nigrum) 7.5 mg. ; Sunth (Zingiber Offici-narum) 7.5 mg. ; Chini Kabab (Cubeb Officinalis) 7.5 mg.
Properties
Relieves Fatigue – Muscular, Nervous, Sexual. Tones up Neuro-glandular, Neuro-muscular, and Genito-Urinary systems. Corrects constipation and dyspepsia. Re-moves mental tension and anxiety. Makes one alert, energetic, fresh and vigorous. It improves health and gives a sense of well being.
Materials & Methods
This clinical trial on the drug was undertaken on patients who underwent recanalization operations at the indoor Dept. of Plastic Surgery of the Medical College, Calcutta. Patients were randomly divided into two groups, called Group A and Group B. Group A was given the drug and Group B formed the Control Group and was not given any drug. Full history was taken including the reason that forced them to come for recanalization. All patients were examined for the site of the vasectomy scar, size and the consistency of the testes and epididymis. Routine blood, urine, blood sugar, blood urea tests were done. – Semen analysis was done before recanalization and after one month of recanalization and later repeated once a month for three months Prostitic smear culture was done were found necessary. Cases of varicocele were excluded from the study. First semen analysis was done one month after recanalization operation The period of therapy was three months starting one month after recanalization and after first semen analysis was done.
Semen analysis was done before ‘he operation and all the cases showed o sperms. Consistency and size of the testes were normal in all the cases.
On the whole, 16 cases were included in Group A and 16 cases in Group B. The study was conducted during the period from March 1982 to March 1983.
Recanalisation of the Vas Bilateral Recanalisation was done under general anesthesia using ophthalmic loupe magnification. During operation, it was observed that there was free oozing of semen from the proximal cut ends of the vas and it was either milky or watery. Post-operative recovery was uneventful. The patients were discharged with advice to use a suspensory bandage for four months and to attend the follow-up clinic regularly once a month for four months. Semen analysis was done after one month of recanalization operation and was repeated every month for three months (in Drug and Control Groups).
Time interval between Vasectomy & Recanalisation :
The interval between vasectomy and recanalization ranged from 1-15 years. The largest number of 15 patients (46.9%) had an interval of 6-10 years. (Table I)
Age Groups :
Among the total of 32 cases, there were 14 cases (43.75%) in the Age Group of 26-30 Yrs., 14 cases were in the Age Group of 31-40 Yrs and 4 cases (12.5%) in the Age Group of 41-46 Yrs. (Table II)
Dosage :
The drug was started in Group A after o month of Recanalisation operation. It was given in a dose of 2 tabs. three times a day for a period of three months. Group B, the Control Group did not receive any drug.
Semen Analysis after Recanalisation Operation in both the groups :
(Group A Drug Group; Group B Control Group) Semen analysis was done in all the 32 cases (Group A + Group B) after recanalization operation but before starting the drug in the Drug Group. An interval of one month was given after the operation for post-operative recovery and also to ensure proper establishment of semen flow after years of obstruction and suppression.
Semen analysis in both the Groups showed sperm count ranging from less than 20 mIns/m1 to 80 mins/mi. Details are given in Table III.
Sperm Motility :
Both Groups (Before starting the drug) The First Semen Analysis after Reca-nalisation operation in both the groups, showed that the percentage of motile sperms ranged from less than 20% to 40%.
Sperm Morphology: Both Groups. (Before starting the drug) The first semen analysis after recanalization operation in both the Groups showed that only 20% of sperms had normal complete morphology and 80% had abnormal forms. The details of First Semen analysis as to Sperm Motility and Sperm Morphology are given in Table IV.
Results of Drug Group (Group A) after four Months of Recanalisation: SPERM COUNT After three months of continuous therapy Semen Analysis showed: 7 cases (43.8%) with 80 mIns./m1 and over ; 3 cases (18.7%) with sperm count of 40-80 mins./ml; 2 cases (12.5) with 20-40 mins./ml; and 4 cases (25.0%) with less than 20 miles./ml. of sperm court. Overall, when compared to First Semen Analysis before starting Drug treatment, 11 cases (6.8.8%) showed improvement with Drug treatment in Table V.
Results of Drug Treatment: Sperm Motility & Sperm Morphology :
With treatment Sperm Motility which showed only less than 20% motility before treatment, showed motility of 20.40% in 8 cases (50%)
Sperm Morphology which showed Complete Normal forms of only 20% in all 16 cases, showed Complete forms with 40-80% in 6 cases and 20-40% of Complete Normal forms in 4 cases. That is, 10 cases (62.5) showed improved Sperm Morphology.
The details of Sperm Motility and Sperm Morphology after Drug treatment are given in Table VI.
Results of Control (Group B) after four months of follow- up after Recanalisation :
SPERM COUNT
The semen picture in the Control Group after four months of follow-up was as follows : Over 80 mins /ml-0 ; 41-80 mins /ml-4 (25%); 20-40 mins./m1-4 (25%) ; less than 20 mins./ml-8 (50%). Overall, when compared to First semen picture was taken four months back, 6 cases (37.5%) showed Mode-rate improvement as there was no case showing sperm count of over 80 mins./ml
The Control Group was not Given any drug or placebo. (Table VII).
Sperm Motility & Sperm Morphology-Control Group
After four months of follow-up, repeat semen analysis showed 5 cases (31.3%) had sperms with motility of 20-40% and II patients (68.7%) showed sperms with motility of less than 20%. Overall, when compared to the First semen picture taken after recanalization operation, semen picture showed improvement in 5 cases (31.3%).
Similarly, sperm morphology, in the Control Group, after four months did not show any improvement and was less than 20% of Complete normal forms in all the 16 cases as before.
The details of Sperm Motility and Sperm Morphology after the clinical trial, in the Control Group, are given in Table VIII.
Results: Drug Group and Control Group Compared
When compared to the Control Group, Drug treated Group showed better Sperm Count, and Sperm Motility and an increase in Complete normal sperms and a decrease in abnormal forms. The mean improvement was in 9 cases (56.3%) in the Drug Grow-while the mean improvement in the Cont. Group was in 4 cases (25.0%). The improvement shown in the Drug Group was more than two times when compared to the Control Group (Table IX).
CONCLUSIONS & SUMMARY
- In this Controlled Clinical Trial, the product was given for three months after Recanalisation operation to one Group of 16 patients while the other Group of 16 patients formed the Control, where no drug or placebo was given.
- Semen Analysis was the main criterion for the evaluation of the results of the clinical trial.
- Improvement in the semen picture with Drug treatment was found to be more than two times shown in the Control Group. There was an appreciable increase in the Sperm Count, Sperm Motility and Sperm Morphology with drug treatment.
- The product thus helps in restoring the normal reproductive life of man more encouragingly and rapidly within about three months after Recanalization Ope-ration.
- There was an improvement in general health and a sense of well being in all the patients who received the product All expressed that their sex performance was better after drug treatment. These help in better insemination and improve the chances of the conceive early.
- No toxic or side effects were observed with the use of the product.
TABLE—I
Time Interval between Vasectomy & Recanalisation. N=32
| Time Interval | Group A (Drug) N=16 | Group B (Control) N =16 |
Total N-32 |
|
| 1-5 Yrs. | 4 | 5 | 9 | 28.1% |
| 6-10 Yrs. | 7 | 8 | 15 | 46.9% |
| 11-15 Yrs. | 5 | 3 | 8 | 25.0% |
| Total | 16 | 16 | 32 | 100.0% |
TABLE—II
| Age Groups. | N=32 | |||
| Age Group | Group A (Drug) |
Group B (Control) |
Total N=32 |
% |
| N=16 | N=16 | |||
| 26-30 Yrs. | 6 | 8 | 14 | 43.75% |
| 31-40 Yrs. | 9 | 5 | 14 | 43.75% |
| 41-46 Yrs. | 1 | 3 | 4 | 12.5% |
| Total | 16 | 16 | 32 | 100.0% |
TABLE—III
First Semen Analysis after Recanalisation Operation before starting
Drug Treatment in Group A. N=32
|
Sperm Count in mls./m1 |
Group A (Drug Group) N=16 |
Group B (Control) N=16 |
Total N=32 | |
| Over 80 mIns./m1 | 0 | 0 | 0 | 0 |
| 41-80 mIns./m1 | 2 | 0 | 2 | 6.2% |
| 20-40 mIns./m1 | 5 | 2 | 7 | 21.9% |
| Less than 20 mIns./m1 | 9 | 14 | 23 | 71.9% |
| Total | 16 | 16 | 32 | 100.00% |
TABLE—IV
Sperm Motility & Morphology (Before starting
Drug in Group A). N=32
| Sperm Motility | Group A
(Drug) N=16 |
Group B
(Control) N=16 |
Total
N=32 |
0/0 |
| 41-80% | 0 | 0 | 0 | — |
| 20-40% | 1 | 0 | 1 | 3.1% |
| Less than 20% : | 15 | 16 | 31 | 96.9% |
| Total | 16 | 16 | 32 | 100.0% |
| Sperm Morphology Complete forms | ||||
| 41-80% | 0 | 0 | 0 | |
| 20-40% | 0 | 0 | 0 | |
| Less’than 20% | 16 | 16 | 32 | 100.0% |
| Total | 16 | 16 | 32 | 100.0% |
TABLE—V
Results of drug Treatment: Sperm Count. N=16
| Sperm count in mlns./ml. | Before Treatment | After Treatment | No. of cases improved. | %
Improved. |
|
| Over 80 mins /ml. : | 0 | 7 | 43.8% | 7 | 43.8% |
| 41-80 mIns./ml. | 2 | 3 | 18.7% | 1 | 6.2% |
| ‘0-40 mans./ml. : | 5 | 2 | 12.5% | 3 | 18.7% |
| Less than 20 | |||||
| mIns./ml. | 9 | 4 | 25.0% | ||
| Total | 16 | 16 | 100.0% | 11 | 68.7% |
TABLE—VI
Sperm Motility & Morphology after Drug treatment. N=16
|
41-80% |
0 | 0 | 0 | |
|
20 -40% |
1 | 8 | 7 | 43.8% |
|
Less than 20% |
15 | 8 | ||
| 16 | 16 | 7 | 43.8% | |
| Morphology
(Complete forms) |
||||
| 41-80% | 0 | 6 | 6 | 37.5% |
| 20-40% | 0 | 4 | 4 | 25.0% |
| Less. than 20% | 16 | 6 | ||
| Total | 16 | 16 | 10 | 62.5% |
TABLE—IX
Results control Group after 4 months of Recaualisation operation: Sperm Count.
N-16
|
Sperm Count |
Before Trial | After
4 months |
No. of cases improved | improved | |
| Over 80
mIns./ml. |
0 | 0 | 0 | 0 | 0 |
| 41 —80
mlns/ml. |
0 | 4 | 25% | 4 | 25.0% |
| 20-40
Mlns/ml. |
2 | 4 | 25% | 4 | 12.51),,„ |
| Less than
20 mlns/ml. |
14 | 8 | 50% | ||
| Total | 16 | 16 | 100% | 6 | 37.5% |
TABLE—VIII
Control Group: After four months of recanalization operation; Motility & Morphology.
N=16
| Sperm
Motility |
Before
Trial |
After
4 months |
Cases
Improved |
% of
Improvement |
| 41-80% | 0 | 0 | 0 | |
| 20-40% | 0 | 5 | 5 | 31.3 |
| Less than 20% | 16 | 11 | ||
| Total | 16 | 16 | 5 | 31.3% |
| Sperm Morphology
Complete forms |
Before
Trial |
After
4 months |
Cases
Improved |
% of
Improvement |
| 41-80% | 0 | 0 | 0 | |
| 20-40% | 0 | 0 | 0 | |
| Less than 20% | 16 | 16 | ||
| Total | 16 | 26 |
TABLE—IX
Comparative results in Drug Group & Control Group
| Improvement | Drug Group No. | N-16
Control Group |
||
| Sperm Count | 11 | 68.8% | 6 | 37.5% |
| Sperm Motility | 7 | 43.8% | 5 | 31.3% |
| Sperm Morphology | 10 | 62.5% | 0 | 0 |
| Mean | 9 | 56.3% | 4 | 25% |
ACKNOW LEDGEMENT
We are thankful to the Superintendent & Principal of the Medical College & Hospitals, Calcutta, for the guidance given to us in conducting this clinical trial.
Our thanks to Alarsin Pharmaceuticals, Bombay, for their cooperation.
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