for the use only of a registered medical practitioner or a hospital or a laboratory.

 

USEFULNESS OF FORTEGE IN OLIGOSPERMIA AND LOW MOTILITY SPERMS (A CONTROLLED TRIAL)

by

Dr. R. K. Shelat,- MD, FRCS, FACS (U.S.A.) Dr. (Miss) Muktiben Majumdar, MBBS, DGO; Dr. (Miss) Bhartiben C. Banderia, BAMS, LMP. Dr. (Mrs.) K. N. Basu, MBBS, DGO. Surat General Hospital & Lakhpati Municipal Corporation Maternity Hospital, Surat, Gujarat.

Paper presented at: First Asian Congress of Fertility & Sterility, Bombay: 19-23 Feb. 1977.

 

SUMMARY

48 Cases of Oligospermia and 8 Cases of Low motility with normal Sperm count were divided into two equal groups, the Fortege Group & Control Group.

After the trial of three months, Fortege Group showed normal semen picture among 60.7% of cases overall, while the Control Group showed improvement only in 14.3% of cases.

Cases which improved with Fortege showed an increased quantity of ejaculate.

Apart from improving sperm defects. Fortege gives a healthy sense of well-being & improves sex     performance.

No side effects were observed with Fortege treatment.

 

 

INTRODUCTION

In our country when a couple is childless, the woman is always blamed for the barren mar­riage. In all cases of childless couples, it is im­perative to examine both the wife and the hus­band because the fault of infertility may lie in either of them. In a study of 1000 cases of steril­ity comprising 750 cases of Primary Sterility and 250 cases of Secondary Sterility, Ketkar'4 has reported that both wife and husband were normal in 52.1 %;19.8%; as Female Defective; 23.6% as Male Defective and 4.5% as both De­fective. If this is taken as correct, both wife and husband are almost equally responsible for the barren marriage. Unfortunately, the medical profession today is giving more importance to Female Sterility than to Male Infertility though Male Infertility is as important as Female Steril­ity.

In semen analysis of 1000 cases, Ketkarl4 has reported Mild Hypospermia 7.0%; Severe Hypospermia in 12.0%; Azoospermia in 11.7%; and it was normal in 69.3%. When a man leads a normal sex life, sperm defects are least suspected and so this is often overlooked when a childless woman comes for advice. The mechanisms involved in semen defects except in cases of obstructive ducts are not clearly un­derstood and the use of testosterone and other androgens has been highly disappointing.


MATERIALS & METHODS:

200 couples with a history of barren marriage (Primary Sterility) that attended the Surat Gen­eral Hospital, Lakhpati Municipal Corporation Maternity Hospital and our Consultation Clinic during the years 1975 and 1976, were examined. Those men having varicocele or iymphangiocie and those having a systemic disease like tuberculosis or diabetes and V.Q. cases were excluded from the trial. Those ad­dicted to alcohol or drugs were also excluded from the clinical trial.

The age of the childless couples ranged from 21 to 36 years and the duration of their marriage varied from two to ten years. Semen analysis was done in all the two hundred men, before the trial and was repeated at the end of one month, two months and three months. Testicular biopsy was done in all cases of azoospermia and those cases of obstructive pathology were advised surgical measures. However, semen analysis was not repeated in cases of azoos­permia, obstructive and non-obstructive, and these were excluded from the trial. The trial period was fixed as three months.

Fortege was given in cases of Oligospermia and of Low motility (though with normal sperm count). While one case of Oligospermia re­ceived X capsules, the next one received Y capsules. The same method was followed in cases of Low motility also. Those who received X capsules formed the X Group and those who received Y capsules formed the Y Group. Though X and Y capsules were identically look­ing, X capsule contained placebo, and Y cap­sule contained Fortege equivalent to one com­mercially available tablet. However, the identity of X and Y capsules was verified only at the end of the trial period of three months to avoid any bias, when it was known that X capsules con­tained placebo and Y capsules contained For­tege.



FORTEGE

Fortege is an Ayurvedic preparation and is described to improve the quality and quantity

of semen. It is said to tone up neuro-glandular -and genito-urinary systems, giving vigour, vital­ity and freshness. It is also said to improve sex performance and give a healthy sense of well being.


Each Tablet of Fortege contains in mg:
Kamboji 56.0, Kauncha beej 30.0, Suddha Kachura 30.0, Samudra Sosh beej 15.0, Var­dhara beej 15.0, Asan 15.0, Vardhara mool 15.0, Laving 7.5, Pipar 7.5, Vacha 7.5, Mari 7.5, Sunth 7.5, Chini Kabab 7.5, Akalakara 7.5, Sukhad Ver 7.5, Jaifal 4.5, Javantri 3.0, Jeevanti 56.5.

Fortege was selected for the clinical trial mainly because it is non-hormonal and as such is devoid of the side effects of androgens com­monly used.


SEMEN ANALYSIS:


Semen collection was done at the pathologi­cal laboratory and not at the residence and was examined within one hour of collection. An abs­tinence of two days was advised before exami­nation. This procedure was followed for repeat semen examinations also. Testicular Biopsy was done in all cases of azoospermia and those with obstructive pathology were advised surgi­cal measures.

Sperm count of 30 millions/mi. and over with motility of 60% and over were taken as normal. The quantity of 2-3 ml. of the ejaculate was taken as normal and abnormal forms up to 20% were taken as normal.

Among 200 semen analysis 60.5% (121) had normal sperm count with normal percen­tage of motile sperms, 24% (48) had Oligosper­mia. 4% (8) had Low percentage of motile sperms, though the sperm count was normal.

There were 23 cases of azoospermia (11.5%) among the total 200 cases. Testicular Biopsy showed that 4.0% (8) had obstructive type of azoospermia and 7.5% (15) had non ­obstructive type of azoospermia.

Among the cases of Oligospermia, generally low sperm count was inconsistent with Low motility.

The quantity of the ejaculate was 2-3 ml. and the abnormal forms did not exceed 10-20% and as such were within normal limits.

The details of semen examination in 200 men are given in Table No. 1.


TABLE N0.1-SHOWING RESULT OF SEMEN EXAMINATION:

N0. OF PAGES

Normal Semen (30 million/ml. and over

121

60.5%

Oligospermia (10-30 millions/ml.)

48

24.0%

Low Motility but of normal sperm count (40% & less)

8

4.0%

Azoospermia - Obstructive

8

4.0%

Azoospermia – Non obstructive

15

7.5%

 

200

100.0%


FORTEGE TREATMENT:


48 cases of Oligospermia and 8 cases of Low motility though of normal sperm count, a total of 56 cases were put on clinical trial. 24 cases of Oligospermia and 4 cases of -Low motility received X capsules (Placebo), 2 cap­sules, three times a day ,for three months and the other 24 cases 'of Oligospermia and 4 cases of Low motility received Y capsules (Fortege) similarly. As such 24 cases of Oligospermia and 4 cases of Low motility formed the Control Group and the other 24 cases of Oligospermia and 4 cases of Low motility formed the Fortege Group

 

 

RESULTS:

OLIGOSPERMIA: FORTEGE AND CONTROL CROUP

Among 24 cases of Oligospermia, with For­tege treatment sperm count increased consistently from month to month, varying from 10 to 20 millions/ml. At the end of three months, 15 cases (62.5%) showed normal sperm count (50-60 millions/ml) with 50-60% of motile sperm. Only 9 cases (37.5%) did not show nor­mal sperm count, through each showed some increase in the sperm count and the percentage of motile sperms. For the purpose of improve­ment with Fortege treatment, a minimum 50-60 millions/ml. with 50-60% of motile sperms were taken as improvement.

Among 24 cases of Oligospermia of the Con­trol Group, at the end of three months, only 4 cases (16.7%) improved and there was no im­provement in 20 cases (83.3%).­

­ The details of response in Fortege and Con­trol Groups in cases of oligospermia are given in Table No.2.

TABLE N0. 2-RESPONSE TO FORTEGE AND CONTROL GROUPS IN OLIGOSPERMIA :


OLIGOSPERMIA                                     TOTAL      IMPROVED   %                NOT IMPROVED             %

Fortege (Y Capsules)                                    24                  15            62.5%                     9                              37.5%

Control (X Capsules)                                    24                  4              16.7%                     20                            83.3%

 

LOW MOTILITY:

Response: Fortege and Control Groups.

Among the four cases of Low motility with normal sperm count treated with Fortege, motil­ity increased to 50-60% and over in 2 cases (50%). In the Control Group, there was no improvement in the percentage of motile sperms even in a single case. The details are given in Table No.3.


TABLE N0. 3 - RESPONSE: LOW MOTILITY WITH NORMAL SPERM COUNT: FORTEGE AND CONTROL GROUP:

 LOW MOTILITY WITH

NORMAL SPERM  COUNT(40%)

TOTAL

CASES

 

IMPROVED

50-60% AND  OVER

 


%

 

NOTIMPROVED

 

 

 

%

 

Fortege : (Y Capsules)

4

2

50%

2

50%  

Control: (X Capsules)

4

-

-

4

100%

 

OVERALL RESULTS TO FORTEGE THERAPY:

 

Among 24 cases of Oligospermia 15 cases improved with Fortege. Among 4 cases of Low motility with normal sperm count, 2 cases im­proved with Fortege. On the whole 17 cases out of 28 cases, that is 60.7% showed normal sperm count and motility and only 11 cases, that is 39.3% did not improve, after Fortege therapy.

Among 24 cases of Oligospermia of the Con­trol Group, 4 cases improved. Among 4 cases of Low motility with normal sperm count, of the Control Group, none improved. On the whole, out of 28 cases of the Control Group only 4 cases, that is 14.3% improved and 85.7% did not improve.

The details of overall response in Fortege and Control Groups are given in Table No-4.

 

 

TABLE N0. 4 -- OVERALL RESPONSE TO FORTEGE THERAPY:

 

TOTAL CASES                    IMPROVED           % '           NOT IMPROVED %

Fortege (Y Capsules)                           28                                            17            60.7%                     11                            39.3%

Control (X Capsules)                           28                                            04            14.3%                     24                            85.7%

 

 

QUANTITY OF EJACULATE:

 

Though all 56 cases under trial had ejaculate of not less than 2 mi. those 17 cases who im­proved with Fortege showed an increased quantity of ejaculate ranging from 0.2 to 0.5 ml.

 

SIDE EFFECTS:

        No side effects were observed with Fortege treatment.

 

 

CONCLUSIONS:

 

In male infertility, the main cause is sperm defect. Fortege has given good response in treating cases of Oligospermia and Low motility with normal sperm count, which together form the bulk of sperm defects. Male Infertility is al­most-as common as Female Sterility. Routine use of Fortege for husbands will help childless couples where Oligospermia and Low motility are the under lying causes of Male Infertility. Apart from improving sperm defects, Fortege gives a healthy sense of well-being and im­proves sex performance.


SUMMARY:

 

48 cases of Oligospermia and 8 cases of Low motility with normal sperm count were di­vided into two equal Groups, the Fortege Group and Control Group. Semen was examined be­fore the trial and was repeated once in a month for three months. After the trial of three months, Fortege Group showed normal semen picture among 60.7% of cases, overall, while the Con­trol Group showed improvement only in 14.3°I° of cases.


ACKNOWLEDGEMENT:

I am thankful to the Hospital authorities for giving the necessary laboratory facilities. I am also thankful to Alarsin Pharmaceuticals, Bom­bay-23, for the supply of Fortege and Placebo capsules.

REFERENCES:

1. Baui, M.K. et al: Male Factor in Sterility: Proceeding of the XVI All India Obst. & Gynec. Congress, 10-12 March., 1972.

2. Cooper, A.J.: The problem of Endocrine Impotence: Brit. Med. Jr. April 1, 1972.

3. Gogate, AX: Treatment of Infertility with a new oral Androgen Mesterolone: Bombay Hospital Journal: Vol. 1fi, No.4,1974.

4. Gupta, L.N. & Saluja, J.S.: Role of Fortege in Oligospermia: Current Med. Pract. Vol. 19, No. fi, Page 272-273, June, 1975.

5. Joshi, S.K.: Syndrome of. `Dhaat': Mah. Med. Jr. Dec., 1965.

fi. Kaushalya Mehta: Infertility: Proceeding of the XVI All India Obst. & Gynec. Congress, 10-12 March, 1972.

7. Kawathekar, P. & Kasturi Lal: Observations of some aetiological aspects of Infertility in Gulbarga (Mysore. State): P r,oceeding of the XVI All India Obst. & Gynec. Congress, 10-12 March, 1972.

8. Purandare, S.M. & Natarajan, P.G.: Semen Analysis: Current Med. Pract., May, 1974.

9. Rajan R.: "Reproductive problems of the . Male: An Experience with 210 Infertile Men": Kerala Med. Jr. Vo1.16,1976.

10. Saxena, S.C.: Some aspects of Male Infer­tility: Proceeding of the XVI All India Obst. & Gynec. Congress, l0-12 March, 1972.

11. Saxena, S.C. & Pathak, R.K.: Clinico­pathological Study of Infertile Couple: Pro­ceeding of the XVI All India Obst. & Gynec. Congress, l0-12 March, 1972.

12. Sukhtankar, V.R.: A peculiar anxiety Syn­drome nightmare of millions: Indian Pract. Dec., 1960.

13. Sulochana Gunasheela: A cynic looks at Infertility: Proceeding of the XVI All India Obst. & Gynec. Congress, 10-12 March, 1972.

14. Mrs. Vimal Ketkar: Sterility: Mah. Med. Jr. Vol. XI 1, No. 10, Jan. 1966.

 

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