Dr. Dhiraj Gada

for the me only of a rel;utered rneduul pnuctu,oarW or u iuA+pitd onu btxuurory




(A Retrospective study - 1977-84)



Dr. Dhiraj Gada, M.D:; Obstetrician and Gynaecologist,

Dr. C.M. Shah, M.S.,


Gada Nursing Home, 70, Jawahar Marg, INDORE 482 004, M.P. (INDIA)

The Antiseptic: Vol : 84,5, P P 267 to 274, Mar 1987







Treatment of infertility forms a major work-load in the practice of a Gynecologist in India. About 40 per cent of infertility is due to male factor and unfortunately there is no easy solution to it. In the male dominated society of our country, the female partner is always blamed and is always investigated without even interviewing the male partner though it is far easier and less expensive to examine the husband than the female partner.


This study was undertaken to assess or compare the efficacy of Clomiphene or Fortege. These drugs were randomly used in the management of oligospermia without knowing how far these were useful. The analysis is made retrospectively and the findings are given in this study.




Herbal Drug y;iachtablet contains in mg.:- Kamboji (Breynia Patens) : 56.(., ,G Kauncha Beej (Mucuna Pruriens): 30.0; Suddha Kachura (Detoxicated Strychnos Nuxvomica):30:0, Samudra Sosh beej (Argyreia speciosa): 15.0, Vardhara beej (Rourea Santaloides-seeds): 15.0, Asan (Withania Somnifera):15.0, Vardhara mool (Rourea San taloides-root): 15.0, Laving (Caryophyllus aromaticus): 7.5, Pipar (Piper Longum):7.5, Vacha (Acorus Calamus): 7.5, Mari (Piper Nigrum, Black Piper): 7.5, Sunth (Zingiber Off icinalis): 7.5, Chini Kabab (Cubeb Officinalis): 7.5, Akalakara {Anacylus pyrethrum}: 7.5, Sukhed ver (Santalum album): 7.5, Jaifal (Myristica Fragrans):

4.5, Javantri (Myristica Fragrans-arillus): 3.0 and Jeevanti . (Leptadenia Reticulata): 56.5.


The properties of Fortege are given as follows:

Safe and non hormonal drug to relieve Fatigue (muscular, nervous, sexual, physical, mental), Stress and Strain. Corrects sperm defects. Improves quality and quantity of semen. Tones up neuro-glandular, neuro-muscular, genito-urinary and gastro-intestinal systems. No draw-backs like stimulation and excitation followed by exhaustion id depression. No euphoria, no drowsiness, no hangover. Relieves constipation. Controls hyper-excitability of higher and lower sex centres. Improves sex, performance. Keeps one fresh, alert, active and vigorous. Gives a sense of well-being.




This study covered a period of eight years from 1977 to 1984 and a total number of 1578 cases of infertility were registered during the period. When a female partner was registered for infertility we insisted on investigating the husband first and later investigated the wife as a routine. Only those cases of uncomplicated oligospermia whose wives were found normal were taken up for this study.


Semenogram was done in every case and at least two semenograms were done before confirming the diagnosis as a case of oligospermia. Then treatment was given with Clomiphene Citrate or Fortege randomly, continuously for three months when semen analysis was repeated. Those cases who showed considerable improvement were continued with the same drug for a further period-of 3-6 months. Those cases who showed no improvement with the first course were changed to the other drug, that is those who received Clomiphene before were given Fortege and vice versa. This was continued for 3-6 months before final assessment was made. Semen analysis was made every three months.


No other drug other than Clomiphene or Fortege was used in these patients. However, in a few patients who showed significant number of pus cells under HPF antibiotics were used for a limited period in the beginning.


All the patients were instructed to avoid tight undergarments, hot water bath, tobacco and alcohol.




The following investigations were done:

Semen analysis before starting treatment and repeated every three months upto end of nine months. Haemogram: Blood Sugar:  VDRL; Urine Examination. X-Ray chest: prostatic smear examination. Hormonal investigations could not be done for want of facilities.                      




Those cases that showed sperm count of 15-40 million/ml and/ or sperm motility of less than 40 per cent were labeled as Mild type of oligospermia. If the sperm count was less than 15 millions/ml and/or sperm motility of less than 15 per cent, these cases were labeled as of severe type of oligospermia. Two or more semenograms were taken before final diagnosis.





Among the total of 1578 eases registered for infertility 226 cases(16.8 per cent) were lost to follow-up. Before completion of investigations, 196 female partners conceived. Both partners were normal in 234 cases (14.8 per cent) Both partners were abnormal (Couple Infertility) in 110 cases (7.0 per cent). There were 278 cases (17.6 per cent) of Female Factor. . 494 cases (31.3 per cent) were of Male Infertility where the female partner was normal and the Infertility was solely due to the male factor. Among the cases of sterility, Primary and Secondary Sterility were in the ratio of 5:3 respectively. (Table I)


Table-1: Couples registered for treatment of Infertility 177-84 :1578

                  No.                                                       %

Lost to follow up                                     : 266                                                     16.9%

Conceived before completing Investigation: 196                                                     12.4%

No abnormalities detected(Both partners) : 234                                                     14:8 %

Both partners had Abnormality                : 110                                                     7.0%

Only Male Factor                                   : 494                                                     31.3%

Only Female Factor                               : 278                                                     17.6%

                        Total                             : 1578                                                   100.0


Primary Sterility: Secondary Sterility 5:3



There were 494 cases of abnormal semenogram whose wives were investigated and found normal. Among these, 65 cases were of azoospermia, 10 cases of necrospermia, 9 cases of oligospermia with bilateral varicocele and 410 cases of uncomplicated oligospermia (229 cases of Mild Oligospermia and 181 cases of Severe Oligospermia). All the 84 complicated cases were referred to the Surgeon for testicular biopsy and follow-up. Those 410 uncomplicated cases of oligospermia were taken up in this study. (Table. II)


Table-II : Only Male Factor (494): Semenogram Remark


Semenogram .             No.of cases                  %                      Remarks

Azoospermia :               65                                 13.2%               Referred to Surgeon

Necrospermia :              10                                 2.0%                 for testicular Biopsy

Surgical Pathology:        9                                  1.8%.                and Follow-up

Mild ((229) and

Severe (181)                  410                               83.0%               Analyzed

Oligospermia                                                                             for this study


Total:                            494                               100.0%



AGE GROUPS                                                                                                                                                                                     

The age group of 31-40 years was the largest with 159 cases (38.78%).



Table - III: Age Groups (410 cases of Oligospermia)


Age group                     No. of cases                                          %


20-30 Years                               100                                           24.39%                        

31-40 Years                               159                                           38.78%

41-45 Years                               99                                             24.15%

46-50Years                                52                                             12.68%

Above 50 Years                         0

Total                                         410                                           100.00


CLOMIPHENE CITRATE AND FORTEGE GROUPS: Mild and Severe cases of Oligospermia:


There were 104 cases of Clomiphene treated cases and 125 cases of Fortege treated cases among the total of 229 cases of Mild Oligospermia and among 181 cases of severe Oligospermia 86 cases were in the Clomiphene group and 95 cases were in the Fortege Group. Total cases treated with Clomiphene Citrate were 190 and total cases treated with Fortege were 220. (Table IV)


Table-IV: Clomiphene and Fortege Groups: Mild and Severe cases


Group                           Total cases       Mild      %                     Severe              %

Clomiphene cases                     190       104       54.7%               86                     45.3%

Fortege cases                           220       125       56.8%               95                     43.2%

Total                                         410       229       55.9%               181                   44.1%






In the Group which was started with Clomiphene Citrate, the dose of Clomiphene Citrate was 50 mg per day for the first three months. Improved cases were continued with Clomiphene Citrate for a further period of 3-6 months in the same dosage. It was discontinued if the wife conceived before that period. Those cases which showed no improvement with the first course were changed




In the group where treatment was started with Fortege, the dose of Fortege was 2 tabs, three times a day for the first three months. Improved cases were continued with Fortege in the same dosage for a further period of 3-6 months. The drug was discontinued in case the wife conceived before that period. Those cases that did not show improvement with the first course of three months were changed to Clomiphene Citrate.




The case was classified as improved if the sperm count increased to over 40 millions/ml and with sperm motility of 50 percent -.and over.




First three months


Out of 104 cases of Mild Oligospermia, 32 cases (30.8 per cent) showed improved semenogram and 72 cases (69.2 per cent) showed -No Improvement. Out of 86 cases of Severe Oligospermia, 19 cases (22.1 per cent) showed improvement and 67 cases (77.9 per cent) showed No Improvement. Taking all the 190 cases. 51 cases (26.8 per cent) showed improvement and 139 cases (73.2 per cent) showed No Improvement. (Table V)



TABLE-V: Results of Clomiphene treatment (I Course).                                                           


Type                 No.of cases       %         Improved           %         Not Improved     %

Mild                              104      100%                32         30.8%              72         69.2%

Severe                          86        100%                19         22.1%              67         77.9%.                                     

Total                 .           190      100.0%             51         26.8%              139       73.2%                                                              


RESULTS OF FORTEGE GROUP: First three months -                                                                                                                                     

Out of 125 cases of Mild Oligospermia of this group, 102 cases (81.6%) showed Improvement and 23 cases (18.4%) showed No Improvement. Out of 95 cases of severe oligospermia, 42cases (44.2%) showed improvement and 53 cases (55.8%) showed No Improvement. Taking all, the 220 cases of Fortege Group, 144 cases.(65.5%) showed improvement and 76 cases(34.5%) showed No Improvement. (Table VI)                                                                                                                                                                                                                    


TABLE-VI: Results of Fortege treatment (I Course).


Type                 No.of cases       Improved           %         Not Improved     %

Mild                             125       102                   81.6%               23         18.4%

Severe                          95         42                    44.2%               53         55.8%

Total                             220       144                  65.5%               76         34.5%




Number of cases available for Clomiphene treatment and Fortege treatment:


There were in all 215 cases of No Improvement, 139 from the_ Clomiphene group and 76 from the Fortege group. However, 42 cases were not available for Crossover (Exchange) treatment for one reason or other. So on the whole 63 patients were given; Clomiphene and 110 cases were given Fortege in the Crossover treatment (II Course)(Table VII)



Table - VII: Not improved cases available for Crossover Treatment with Clomiphene; Fortege.


Group               Total     Mild      Not       Treated             Severe              Not                   Treated

                        cases               followed                                                 followed

Clomiphene:      76         23         0          23                       53                   13                     40

                                                            (100%)                                      (24.5%) (75.5%)

Fortege:            139       72         14         58                     67                     15                     52

(19.4%) (80.6%)                                     (22.4%)             (76.6%)

Total:                215       95         14         81                     120                   28                     92

(14.7%) (85.3%)                                     (23.3%)             (76.7%)





In the crossover treatment with Clomiphene 14 cases (22.2 %) (10 of Mild type and 4 of Severe type) showed improvement with three months of treatment and 49 cases (77.8%) (13 from Mild type and 36 from Severe type) showed no Improvement. (Table VIII)


Table - VIII: Results of Crossover Treatment with Clomiphene


Type                             Total cases       Improved           %         Not Improved     %

Mild                                          23         10                     43.5%   13                     56.5%

Severe                          .           40         4                      10.0%    36                     90.0%

Total                             .           63         14                     22.2%   49                     77.8%




In the crossover treatment with Fortege, 68 cases (61.8%) (44 from Mild type and 24 from Severe type) showed improvement and 44cases (38.2%) (14 from Mild type and 28 from Severe type) showed No Improvement after three months treatment with Fortege. (Table IX)                                                                                                                                              

Table - IX: Results of Crossover treatment with Fortege


Type                 Total cases           Improved         %         Not Improved                 %

Mild                  58                                 44         75.9%               14                     24.1%

Severe              52                                 24         46.2%               28                     53.8%

Total                 110                               68         61.8%               42                     38.2%




On the whole 253 cases were treated with Clomiphene. Out of them 65 cases (25.7%) (42 from Mild Type and 23 from Severe Type) showed improvement and 188 cases (74.3%) (85 from Mild Type and 103 from Severe Type) showed no Improvement. (Table X)


TABLE - X : Final assessment of results : Clomiphene (I and Crossover)

Type     I(Course)           II (C.O)              Total     Improved           %         Not Improved     %

Mild                  104       23                     127                   42         33.1%               85         66.9%  

Severe              86         40                     126                   23         18.3%               103       81.7%

Total                 190       63                     253                   65         25.7%               188       74.3%




On the whole 330 cases received Fortege treatment. Out of them, 212 cases (64.2%) (146 from Mild Type and 66 from Severe Type) showed improvement and 118 cases (35.8%) (37 from Mild Type and 81 from Severe Type) showed No Improvement (Table XI)


Table   - XI:      Final assessment of results:     Fortege (Iand Crossover)                                                                                                                                                                    

Type     1(Course)          II(C.O.)              Total     Improved           %         Not Imprvd.        %

Mild      125                   58                     183                  146       79.8%               37         20.2%  

Severe   95                   52                     147                   66         44.9%               81         55.1%

Total     220                   110                   330                   212       64.2%               118       35.8%






Out of 253 cases who were treated with Clomiphene Citrate, 65 cases (25.7øk) improved and 188 cases (74.3%) showed No Improvement. Out of 330 cases who were treated with Fortege, 212 cases (64.2øk) showed improvement and 118 cases (35.8%) showed No Improvement. Overall, Fortege treatment showed an excess of 38.5% of good improvement over those treated with Clomiphene Citrate. (Table XII)


Table - XII: Overall Results: Comiphene; Fortege.

Drug                 Total cases       improved           %         Not Improved     %`        Excess Imp in Fortege

Clomiphene :                 253                   65         25.7%   188                   74.3%

Fortege                         330                   212       64.2%   118                   35.8%               38.5%





Out of 65 improved cases with Clomiphene treatment, 20 of their wives conceived giving a conception rate of 30.8% among improved cases only. If all the 253 cases who received Clomiphene Citrate are considered, only 20 of their wives conceived giving a conception rate of 7.9%. All conceptions took place in 3-9 months. (Table XIII)


Conception Rate of the wives of Clomiphene treated Group.


Type                             No-of cases                   Wives conceived            Conception Rate

Mild impr. cases                        42                     16                                 38.1%

Severe Impr cases                     23                      4                                  17.4%

Total impr. Cases                       65                     20                                 30.8%

Total treated cases                    253                   20                                 7.9%



CONCEPTION RATE IN THE WIVES OF FORTEGE TREATED GROUP                                                                                                                                       

Out of 212 improved cases with Fortege treatment, 103 of their wives conceived giving a Conception Rate of 48.6%, an excess of 17.8% over Clomiphene treated Group. If all the Fortege treated group is considered out of 330 treated, 103 of their wives conceived, giving a conception rate of 31.2%, an excess of 23.3 % over the Clomiphene treated group. All conceptions took place in 9 months. (Table XIV)



Conception Rate in the wives of Fortege treated Group.


Type                             No of cases       Wives conceived            Conception        Excess

Rate                 Conception

cases rate in

                                                                                                                        Fortege Group

Mild impr.cases                         146                   85                     58.2%               20.1%

Severe impr. cases                      66                   18                     27.3%               9.9%

Total impr. cases                       212                   103                   48.6%               17.8%

Total treated cases                    330                   103                   31.2%               23.3%





Mild side effects of gastric irritation were seen in 32 cases of Clomiphene group and only 3 cases of the Fortege group showed these Mild side effects.. Gastric irritation subsided in both groups when they were advised to take the drug with milk.


There were 4 cases of severe side effects, two of alopecia and two of skin rash among the Clomiphene Group, while severe side effects were nil in the Fortege Group.





Semenogram improved in 65 cases out of 253 treated with Clomiphene, an improvement of 25.7 per cent. Semenogram improved in 212 cases of 330 cases treated with Fortege showing    an improvement of 64.2 per cent, that is, an excess of 38.5 percent improvement over Clomiphene group.


2. Overall conception rate in the Wives of Clomiphene treated group was 7.9 per cent. Overall Conception rate in the wives of Fortege treated group was 31.2 percent that is an excess of conception rate of 23.3 per cent over the Clomiphene group. The increased Conception Rate in the wives of Fortege group can be contributed to better sex performance (80 percent) and better

insemination by the Fortege treated husbands. .


3. Gastric irritation occurred in 32 cases of Clomiphene treated groups while only 3 cases had gastric irritation in the Fortege treated group. There were 4 cases of alopecia and 2 cases of skin rashes in the Clomiphene group, while there were none in the Fortege Group.


4. There was a sense of well being in 80 per cent of Fortege treated Group while in the Clomiphene treated Group only 40 per cent of cases had a sense of well being.


5. There is no room for any bias in this study, because the data is taken from the records available as a retrospective study when Clomiphene and Fortege were used randomly even without knowing which is useful in the treatment of oligospermia.


6. This study has shown that Fortege is a safe and highly beneficial drug in the treatment of oligospermia compared to Clomiphene Citrate in doses of 50 mg. daily.





We are thankful for the Medical Registrars for their cooperation.





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Paper Presented at 5th World Congress on Human Reproduction held at Greece and XI World Congress of Gynecology and Obstetrics at Berlin, September 1985.