Ni Fengxian 1, Li Jun 2, Li Jianxin 1, Han Fang 2, Wang Yuehong 3,Li Xinping 4, Wang Zengjie 1, Lv Linlin
Cooperating Institutions:
   1 )Family Planning Science Academe of Liaoning Province 110031
   2 )Heping Women and Infants Hospital of Shenyang 
   3 ) The Second Clinical School of China Medical University
   4 )Family Planning Service Center of Harbin
   5 )AiMu Medical Science & Technological Company limited of Anshan
   [Abstract] Objective :  To investigate the clinical effect, and acceptability of a new type of MCu intrauterine device (abbr. MCu IUD).
Method :  A total of 1050 MCu IUDs’ clinical observation were made between September 1997 and September 1998 at four clinical centers.  109 cases with MCu IUD inserting were randomly chosen for further comparative investigation.  The follow-up survey rate is > 98℅.
   Result:  Among 1050 cases with IUD inserted for 12 months, the pregnancy rate and expulsion rate were both 0, and the continuation rate was 99.62℅.  Inserting MCuIUD and TCu220C each for 109 cases, after observation for 12 months, it is found that the continuation rate are 99.08 per 100 women and 88.07 per 100 women.   The accumulative pregnancy rates are 0 and 2.75 per 100 women separately.  The accumulative expulsion rates are 0 and 0.92 per 100 women separately.  And the removal rates resulting from side effects are 0.92 per 100 women and 7.34 per 100 women.  Via statistics treatment, p<0.05, so there is apparent difference.  The P of the side effects occurrence rate of the two groups is less than 0.01, which indicates a distinctive difference. 
   Conclusion:  The clinical effect of MCu IUD is superior to TCu220.  It has good contraceptive effect, low expulsion rate, slight side effect, safe and can be widely used, which is the unprecedented effect of IUD in the history of its development both home and abroad.  This product has already gained the national registration certificate of medical devices.  Its widely use provides good opportunities for choosing new contraceptives for most women of child-bearing age.
   [Key words] MCu Intrauterine devices; Research and develop; Clinic; Effect

   In order to further raise the safety, effectiveness of intrauterine contraceptive device (IUD) and lower down its occurrence rate,the Science Institute of Family Planning of Liaoning province and Anshan AiMu Medical Science and Technology Co., Ltd. selected and used new materials and technologies, and developed functional intrauterine contraceptive device (MCu IUD).  To further observe the clinical effect of MCu IUD and its acceptability, 1050 cases of clinical observation were done from Sept. 1997 to Sept. 1998.  Among which, 109 cases were compared and sampled randomly with TCu220C.  The clinical effect was very satisfactory after an observation for 12 months.  The summary report is as follows:

   I Material and Method
   1. MCu IUDs are made of shaped memory alloy filament, which are entirely opened arcuate.  The top end of the arcuate arm is fixed and pressed with copper grains.  The surface area of the copper  is 110mm2 .  Its service life is at least 7 years long.  The related standards and norms on the selected memory alloy material are provided by Beijing Metal Research General Institute.  This kind of metal alloy filament has shape memory function, could be controlled under human body temperature and keep its original shape in the uterine cavity, innoxious, and has good tissue compatibility, thus it is a new kind medical metal material in  medical field.  MCu IUDs are produced by Anshan AiMu Medical Science and Technology Co.,Ltd.  The comparison IUD TCu220Cs, produced by the Forth Medical Devices Production Factory of Tianjin, China, is a worldly-recognized good kind of IUD with a copper area of 220 mm2 .
   2. Selection of the trial women:  22 – 40 years old and healthy, whose menses are regular, without the history of extrauterine pregnancy and hydatid mole; the length of the intrauterine cavity is 6 – 9 cm; the couples live together and are willing to take IUD as the only contraceptive
method.
   3. Removal and insertion method:  The insertion methods for MCu IUD and TCu220C are basically the same.  The removal method is used.  MCu IUD is removed by extractors, which is easy and feasible, while TCu220C is mainly removed by drawing the tail of the filament.
   4. Study method:   In Sept. 1997 – Sept.1998, the trial women were accepted at the clinical centers of the Science Institute of Family Planning of Liaoning province, The Second Hospital of China Medical University etc., and filled acceptation tables together.  The professional clinical doctors inserted IUDs.  The operations followed the contraceptive operation routine. After operation, the normal visits were carried out in 1st, 3rd, 6th, and 12th month.  Among them, 109 cases of MCu and 109 cases of TCu220C were compared with each other.  According to the insertion order of IUD and sticking to random envelops, the trial women were compared randomly.  All the information was put into the computer for treatment.  The Tiefve-Pottor life table was adopted for statistics.  And X2 and t were used for checking their obvious differences.

   II Results
   1. The 1050 trial women to be inserted with MCu IUD were 22 – 40 years old.  Among them, 83.45% were 25- 34 years old.  Pregnancy times: 1 – 6 times.  93.34% of them had 1-3 times of pregnancy and 94.95% only had one parity.  Insertion time:  882 cases (84.01%)in 3 –7 days after the menses, 145 cases after induced abortion (13.81%), 21 cases in breast-feeding time(2.00%).  There was no obvious difference in the basic situation for random comparison for each 109 cases, such as, age, parity, pregnancy time, depth of the uterus cavity, location of uterus, the final result of the last pregnancy, and the use of IUD.  P>0.05, Two groups had comparability.
   2. Analysis of the Using effect:  In the course of insertion, no failure, piercing and infection happened for all the trial women inserted with IUD.  After insertion, normal and routine visits were done in 1st, 3rd, 6th, and 12th month.  The random visit rate is > 98%.  On observation of 1050 cases with MCu IUD inserted for 12 serial month, the continuous using rate was 99.08/100 women with no case of pregnancy and expulsion.  the continuous using rate of the compared groups (except stopping use owing to personal reason):  99.08/100women and 88.99%/100women.  P<0.05, there was obvious difference. See Table 1 and 2.

Table 1 An Analysis of the Clinical Effect of 1050 Cases with MCu IUD Inserted for 12 Months

                                           
Use times 
Accumulated rate
Pregnancy
0
0
With IUD   
0
Unexpected pregnancy
0                 
0
expulsion
0                 
0
Full expulsion
0                
0
Partial expulsion
0
Removal because of illness
4
0.38
Paining
1
0.10
Bleeding
3
0.29
Paining and bleeding
0
0
Pelvic inflammation
0
0
Removal due to other medical reasons
0
0
Stopping use for IUD’s own problems
4
0.38
Stopping use because of other personal reasons
0
0
The general rate of stopping use
4
0.38
The rate of continuous use
99.62
For women, months with IUD inserted
12565
Number of inserted person
1050

Table 2 An Analysis of the Clinical Effect of 109 Cases with MCu IUD and TCu220C Inserted for 12 Months

MCuIUD
TCu220C
No. of stopping use
Accum. rate/100women
No. of stopping use
Accum.rate/100women

Pregnancy

0
0
3
2.75

Pregnancy with IUD

0
0
1
0.92

Accident pregnancy

0
0
2
1.83

 

0
0
1
0.92

Full expulsion

0
0
1
0.92

Partial expulsion

0
0
0
0

Removal owing to illness

1
0.92
8
7.34

Paining

0
0
4
3.67

Bleeding

1
0.92
2
1.83

Paining + bleeding

0
0
2
1.83

Pelvic hematoma

0
0
0
0

Removal owing to other medical reasons

0
0
0
0

To stop use for IUD’s own problems

1
0.92
12
11.01

To stop use owing to other personal reasons

0
0
1
0.92

To omit visits

0
0
0
0

The general rate of stopping using

1
0.92
13
11.93

Continuous use rate

99.08
88.07

Women’s months with IUD inserted

1306
1206
Number of inserted person
109
109

   3. Side effect after inserted with IUDs of two groups, during the random visits in 1st, 3rd, 6th, and 12th month, there was no person had voluntary actions.  Values of MCu IUD group were all higher than that of group Tcu220C.  P < 0.05.  P < 0.01.  There was an obvious difference for these two groups. There were a few trial women who talked about harmful illness voluntarily.  See Table 3.

Table 3 Side-effect Occurrences of 109 Cases with MCu IUD and TCu220C Inserted

Random visits in 6 months
Random visits in 12months
MCuIUD
TCu220C
MCuIUD
TCu220C
n
%
n
%
n
%
n
%
No voluntary reflect action
105
96.33
67
61.47
105
96.33
82
75.23
Profuse menstruation
0
0
9
8.26
0
0
7
6.42
Prolong intermenstrual period and short cycling
1
0.92
6
5.50
2
1.83
5
4.59
Irregular bleeding
0
0
11
10.09
0
0
4
3.67
Paining
0
0
9
8.26
0
0
5
4.59
Leukorrhagia hematoma
3
2.75
7
6.42
2
1.83
6
5.50
Number of person with follow-up visits in fact
109
100.00
109
100.00
109
100.00
109
100.00

Comparing the two groups, P<0.01.

   III Discussions
   1. MCu IUDs strengthen the contraceptive effect because of copper ions, which are released by the fixed and pressed copper grains.  The contraceptive effect of copper ions has been already confirmed, but the academic circles always think that the contraceptive effect is related to the surface area of the copper.  In this report, two different copper surfaces of IUDs were inserted randomly.  For each, 109 cases were observed randomly for 12 months.  The final results were as follows: Pregnancy of group MCu – 0 and group Tcu220C – 2.75/100women.  The surface area of the copper of MCu IUD was 110mm2  while TCu220C was 220mm2. As this report shows, the contraceptive effect to the surface area of the copper perhaps is related to the distributed range of copper ions.  Because few cases are cited in this report, and the time for random visits is short, it is necessary to further certify the relation between big or small surface area of copper and the contraception.  The effective contraceptive area is formed at the two uterine angles by copper ions, which are released by MCu IUD.  They play a role of safeguard fort.  Copper grain bullets on the arcuate end play a role of contraception, such as, killing spermia so as to not entering into the oviduct and killing embryogenesis to prevent implantation.  Therefore, the pregnancy rate of 1050 cases observed and inserted for 12 months is zero, thus lowers down the ectopic pregnancy rate and reaches the satisfactory contraceptive effect.
   2. MCu IUDs apply a special functional and new -type medical metallic material - - special shaped memory alloys with special arches; arcuate arms and uterus cavity are in the same direction. They are taken as the support points in the uterus cavity; the fixed and pressed copper grains are suspended on two arcuate parts of the uterus (the max. horizontal diameter on the bottom of the uterus cavity.).  It undertakes the contraction function of the uterus and is not easy to deform, move downward and displace.  The expulsion rate in clinical observation of 1050 cases after insertion for 12 months is 0.   After comparison and observation, the value of group MCu is lower than that of group TCu220C.
   3. After 12 months, 1050 cases of MCu IUD were observed.  No special records took place.  The comparison between two groups showed that the occurrence rate of the trial without voluntary reflect of MCu IUD was higher than that of TCu220C.  The probability is < 0.05.   So there was an obvious difference.  That is to say, shaped memory alloy has very good tissue compatibility. It has the same clinical suitability with the report 2 of 1981, which was made by someone when using shaped memory NiTi alloy oviduct clamp in clinic.  The surface of MCu IUD is smooth; its supports are thin; its area  touching endometrium is small; Copper grain bullets on the arcuate top are restricted in the uterus angle, where the inner endometrium tissue is thinner than that of the uterine cavity.  For this reason, the side effect, such as prolonged menstrual period, profuse menstruation and irregular bleeding is reduced.  The surface area containing copper is 110mm2 , which is less than other IUDs containing copper.  This can reduce copper ions’ stimulation to the inner endometrium, and low down the occurrence rate of bleeding.  The flexibility of MCu IUD is very weak, but its retractility is strong thus can contact and expand as the uterus does.  This makes it not only reduce paining, but also decrease tissue’s injury and reduce bleeding.
   4. In accordance with the better clinical effects and special “V” form of MCu IUD, it can fit uterus of the normal form with respect to indications.  It is suggested that those whose uterine cavity is flat tri-angle, saddle, has double – angle uterus or the uterine is not integrate can try MCu IUDs.  MCu IUD can be inserted in 3-7 days after menses or after the operation of induced abortion, but it is necessary to be inserted in time.  During postcesarean and breast-feeding period, if one doesn’t have any contraindictions, it can also be inserted and the same good results will be obtained.
   5. MCu IUD can be inserted by “removal method”, which is easy and safe.  During the removal process, an extractor can be used for it is easy and feasible.
   6. MCu IUD without filament can prevent inner genitals from infection and uncomfortable feelings brought by unfamiliar things during sexual intercourse.
   7. As to the form of the uterus cavity, some one divided it into 5 main forms and 4 subsets. People have carried out numerous studies for several years, trying their best to make inserted MCu IUD conform to the form of uterus cavity and reduce failure and uncomfortable feelings caused by incorrect selection of MCu IUD’s type.  At present, MCu IUDs have four kinds of sizes.  In the course of observing 1050 cases, no difficulty and trouble results from its size selection. And at the meantime no data, which influences the clinical effect, is found.  In order to guarantee the clinical effect and to simplify the operation process, MCu IUDs’size selection for clinical use should continually be studied.
Summary
   MCu IUD is made by using shape memory alloy to fix and press copper grains.  The material is innovative; the design is reasonable; the contraceptive effect is good; the expulsion rate is low; the side-effect rate is low; the characteristics of safe in use and easy in operation is unprecedented in IUDs’development history.  Its appearance and widely use provides a new kind of contraceptive device for most women of child-b, earing age. 

Bibliography
   1. Science Institute of Family Planning of Liaoning province etc. “A Comparison of 4 Types of Domestic Intrauterine Contraceptive Devices”.   Fertility and Sterility, Feb. 7, 1992.
   2. Liu Jianhua, Xue Pei. “A Study on NiTi Memory Alloy Clamp Function to Ovary after Oviduct Sterilization”.   Reproduction and Contraception, Oct., (April), 1990.
   3. China Family Planning Commission.  “A Study on the Form of Uterus Cavity after the Insertion of Metallic O Type Ring IUD”.  Thesis Collection of the Scientific and Technological Key Fruits of Family Planning during the Period of the Sixth Five–year Plan
*Ni Fengxian: Science Institute of Family Planning of Liaoning province (Shenyan 110031)
Li Jun: Shenyang He Ping Infants and Women’s Hospital
Li Jianxin: Science Institute of Family Planning of Liaoning province (Shenyang 110031)
Han Fang: Shenyang He Ping Infants and Women’s Hospital
Wang Yuehong: The Second Clinical College of China Medical University
Li Xinping: The Harbin Family Planning Service Center, HeiLongjiang
Wang Zengjie: Science Institute of Family Planning of Liaoning province (Shenyan 110031)
Lv Linlin: AiMu Medical Science and Technology Co., Ltd.

2006年07月26日

A Clinical Report on 1050 Cases with MCu-IUD Inserted

Ni Fengxian 1, Li Jun 2, Li Jianxin 1, Han Fang 2, Wang Yuehong 3,Li Xinping 4, Wang Zengjie 1, Lv L

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