China successfully launching Billings Ovulation Method

Shao-Zhen QIAN
Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai 200031, China

This paper was presented at the International Jubilee Conference, 50th Anniversary of Billings Method, UNiversity of Melbourne,
Australia, conducted by Ovulation Method Research & Reference Centre of Australia, March 28-30, 2003.

In the 30 years fertile life of women, only a few days in each cycle are fertile and the rest of time infertile. People of
insight have long considered making use of this natural phenomenon to regulate fertility. Early methods of natural family
planning (rhythm, basal body temperature, symptothermal, etc.) are unsatisfactory for fertility regulation and the Chinese
people did not accept them. In the early 60’s, Drs. J.J. and E.L. Billings and their colleagues discovered the
interrelationship between the cervical mucus and the cyclic changes in the ovarian hormones and fertility and alleged the
use of mucus symptom as the main index of ovulation and fertility applicable to all phases of female reproductive life.
This is a milestone in the study of natural family planning.

Since the official introduction of the Billings Ovulation Method (BOM) into China by the
Chinese Ministry of Health in 1995, the method has been distributed to almost every corner of
China, including the industrial and agricultural areas and the minority regions. Chinese women of
different strata and ethnic groups readily understand the meaning of the mucus patterns described
in the Billings books and all of them accept the method. After teaching, most subjects are able to
37,000 BOM recognize the peak symptom from the first cycle and the rest from the second cycle, except in a
teachers trained few (around 1%) having anovulatory cycles as confirmed by plasma hormonal assay.
Chinese Family Planning workers not only advocate fertility control but also fertility promotion
2.7 Million fertile for those without children. The BOM is a bidirectional approach that can be used for both
couples in regular purposes and is becoming one of the most favoured methods in China. Since it is simple to learn,
use cost free, non-invasive, has no side effects and, in particular, it is the most effective way of
fertility regulation in all conditions, as breastfeeding, irregular cycle, pre-menopause, coming off
success rate 99% contraceptive medication or during emotional and physical stress.
Fourteen BOM Centres have been established in China at the most strategic areas for fertility
abortion rate regulation and 36,845 BOM teachers have been trained. A certain percentage of the teachers were
dramatically trained by the Australian Teaching Group led by Drs JJ and EL Billings. Up to date the method
reduced has been regularly used in more than 2,686,400 fertile couples for avoiding pregnancy, the overall
success rate being around 99%; In addition, there were 14,524 among 45,280 infertile couples
32% of infertile (success rate 32.1%) who were overjoyed to obtain their children by the use of BOM. The
couples give birth common people affectionately called these kids the Billings babies. BOM or mucus observation is
now the primary treatment for couples presenting at the 14 Centres and neighboring clinics
experiencing difficulties in conceiving. Through field trials we also confirmed the fact that mucus
observation not only enables the women to understand their fertile status, but is also helpful to
their reproductive health. Many women consulted gynecologists for an early diagnosis and
treatment, when they observed abnormal mucus symptoms.

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 Table 1. Artificial abortion rates in Community A and B in 2002

Community A (BOM widely used) B (BOM seldom used) P

Total fertile women 36,240 49,042
Artificial abortion in 2002 221 1992
Abortion rate 0.61% 4.06% <0.01

In certain localities where the BOM has been widely used, not only the birth rate but also the artificial abortion rate is
significantly decreased. In Community A of one municipality, the BOM was widely spread, the yearly artificial abortion
rate in 2002 being 0.61% (per 100 fertile women), while in the neighboring Community B, where BOM was seldom used,
the rate was 4.06%. which was almost 7 times that of A, the difference being highly significant (P<0.01, Table 1). The
basic conditions of the two communities were similar and their artificial abortion rates in the past had been also similar.

The intrauterine device (IUD) is the most popular contraceptive method used in China. We have done a randomized one-
year parallel comparison of the efficacy of BOM and TCu220c in avoiding pregnancy. TCu220c is a widely used IUD in
China. One thousand five hundred and fifty-six fertile women of different educational levels were enrolled and randomly
classified into 2v groups, one using BOM and the other, IUD. From Table 2, it can be seen that both the pregnancy and
the discontinuation rates are much lower (P<0.01- P<0.001) in the BOM than in the IUD group. Besides, in the IUD
group, there were 15 expulsions and 38 removals due to side effects (pain/bleeding); thus the total use-related
discontinuations amounted to 65 cases (12 pregnancies and 53 expulsions and medical removals). In the BOM group only
5 pregnant cases (all use-related) were discontinued and there were no side effects.

Table 2. Gross cumulative 12-month life-table (Tietze) event rates (mean ± SE %)

BOM IUD P
Pregnancy 0.5 ± 0.2 2.0 ± 0.6 <0.01
Expulsion 2.6 ± 0.7
Medical removal 6.3 ± 1.0

Use-related discontinuations 0.5 ± 0.2 10.6 ± 1.2 <0.01

Non-medical discontinuations 3.1 ± 0.9 0.5 ± 0.3
Loss to follow-up 1.0 ± 0.3 1.1 ± 0.3
Continuation rate 96.4 ± 0.6 89.3 ± 1.2 <0.01

Continuation cases 966 587

Women-months of use 9,870 6,299
Total number of cases 992 662

The BOM results in China exerted a big impact on both the Chinese community and the medical circle and there were 48
papers, broadcasting stations, TV stations and 5 journals reported the news of Drs JJ & EL Billings and their wonderful
method. In most provinces, the BOM has already been incorporated into the Government Family Planning Programme as
one of the methods of choice by the fertile couples.

The method is highly efficient only when a series of precautions and regulations are strictly followed. Inappropriate use
would result in higher failure rates, as in preliminary trials in China (1989) and some other places. Drawing a lesson from
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the early work, we always stick to the authenticated Billings teaching materials. In China only the authenticated BOM
materials (Chinese translation, with the approval of WOOMB) are used and nobody is permitted to rewrite, revise or
modify them. In China, the BOM book, booklet, wall charts, slide rule, etc. are among the most popular reference
materials for family planning. We also provide these materials to Chinese-speaking peoples outside China.

We pay much attention to the Teacher-training course and the women-teaching course, as well as an adequate guidance
system and regular follow-up visits to the couples. Such a programme not only imparts scientific knowledge but also
provokes and maintains the initiative of the women and their husbands, who are invited to participate in every other
follow-up interview. Qualified teachers, the acquisition of BOM knowledge by the participants, the women’s motivation
and the husbands’ cooperation are the key points for the successful implementation of BOM.

Conclusions

1. The BOM is well accepted by different strata Chinese people;

2. The use-effectiveness of BOM is much higher than that of TCu220c, with significantly lower pregnancy rate and
discontinuation rate (P<0.01);
3. The extensive use of BOM will significantly decrease the artificial abortion rate;
4. In infertile couples of unknown cause, the BOM is the method of choice in achieving pregnancy

Evaluation of the Effectiveness of a Natural Fertility Regulation Programme in China

Shao-Zhen QIAN, De-Wei ZHANG, Huai-Zhi ZUO, Ren-Kang LU, Lin PENG, Chang-Hai HE and the
Chinese Billings Ovulation Method Collaboration Programme* #

Professor S. Z Qian is a Professor of Pharmacology at the Shanghai Institute of Materia Medica, Chinese Academy of Sciences, and
Editor-in-Chief of the Asian Journal of Andrology. He presented this paper at a Congress organized by the Centre for Study and
Research in the Natural Regulation of Fertility, Universita Cattolica del Sacro Cuore, Rome, Italy, on 8 September, 2000. The
Congress had the general title of "The Woman of Today and Her Identity: Femininity, Fecundity and Procreation ", and was part of a
world meeting of university professors from 3-10 September 2000, forming part of the celebrations of the Great Jubilee Year 2000.

* Composed of Billings Ovulation Method Research & Training Centres in Nanjing, Anhui, Kunmin and Shanghai
# Correspondence to Professor Shao-Zhen QIAN, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai,
200031, China. Fax +86-21-64742629

1. Introduction

Natural fertility regulation (NFR) methods could provide family planning (avoiding or achieving pregnancy) naturally
through conforming to the women's reproductive cycle without the use of drugs or devices. NFR originated about 60
years ago from the rhythmic method, but this method was not scientifically based. Its deadly shortcoming is the
prediction of the coming events on the basis of the past rhythm and is therefore destined to be inaccurate with a failure
rate of more than 20%. A milestone in the NFR study is the discovery of the intrinsic relationship between the cervical
mucus, the hormonal balance and the fertility status of women by the Billings group. It was shown that the changes in the
cervical mucus correlated with the sex hormone levels in the women,1,2 thus the fertile status could be determined by
observing the characteristics of the cervical mucus at the vulva.3,4 In this way the Billings Ovulation Method (BOM)
overcomes the fatal weakness of early natural family planning methods in predicting the current events on the basis of
past happening, and lays the foundation of scientific NFR research.

There have been many reports on BOM field trials all over the world.5-11 They all reached a common conclusion, i.e. the
BOM had a very low method-related pregnancy rate and a consistently high continuation rate. Since the preliminary trial
of the BOM in China in 1990 and the official introduction of the method by the Chinese Ministry of Health in 1995, the
method has been widely used in China both for avoiding and achieving pregnancy with promising results.12-16

2. Design and Methodology

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In China the BOM has been used in more than 156,400 fertile couples for avoiding pregnancy and 3,268 infertile couples
for achieving pregnancy. In well-designed field trials we studied the acceptability and use-effectiveness of the BOM and
the comparative efficacy of the BOM and an intrauterine device in avoiding pregnancy. In these trials we paid much
attention to the following items:

2.1 Qualified Teachers. The Billings teachers (nurses or midwives) had themselves been trained and examined by
authenticated Chinese and Australian (during site visits) doctors. Only those who obtained good scores were awarded the
certificate of "Billings teacher". In the majority of cases, the teachers were married young women with a long experience
of using the BOM for the avoidance of pregnancy.

2.2 Competent Teaching Course. All women accepting the BOM were trained by weekly interviews for 1 month under
the supervision of Billings teachers. In the training, in addition to the principal BOM knowledge, the following key points
were stressed:

(a) Mucus Symptoms. The identification of mucus depends mainly on the vulval sensation and to a lesser extent on its
appearance; in some women no mucus may be seen and the only signs of the fertile days or the beginning of the fertile
days are a wet/slippery sensation and a soft and swollen vulva.

(b) The Early Day Rules and the Peak Rule should be strictly observed. If the Peak symptoms are not clear (no
slippery/lubricative sensation at the vulva), one should continue to follow the Early Day Rules.

2.3 Subject-screening Procedure. After the training, every subject was interviewed to see whether she could proficiently
master the BOM. Those who could not identify the mucus symptoms were either allocated a special tutor to help them or
screened out. This measure was intended to ensure everybody participating in the study mastered the BOM.

2.4 On-the Spot Guidance and Regular Follow-up Visits. During the trial a teacher was assigned to take care of 20
women as their on-the-spot guide. Arrangement was made so that women could get in touch with the teacher at any time
they wished. The responsible teacher should be clearly aware of the cycle pattern, in particular the fertile days of every
woman they guided. The principal investigator of the centre interviewed the volunteers biweekly (every other visit as
arranged by the responsible teacher) in the first 2 months and then monthly (at the time of changing mucus symptoms) to
check their personal record, monitor the women's comprehension of the rules, and reinforce their motivation and spousal
support (husbands were invited to participate in every other visit). At the end of the 2 months the responsible teacher and
the principal investigator could decide that the couples were now autonomous. The woman not available for follow-up
interviews for three consecutive times was considered lost to follow-up.

It is generally accepted that the acquisition of BOM knowledge by the participants, the women's motivation and the
husbands' cooperation are the key points for the successful implementation of the BOM. Our programme not only
imparted scientific knowledge but also provoked and maintained the initiative of the women and their husbands. Thus the
result of the present study is highly rational and reflective of the scientific essence of the BOM.

Table 1. Base-line characteristics of subjects

TCu220c (n = 662) BOM (n = 992)

(mean ± S.D.) (mean ± S.D.)

Age (years) 27.8 ± 3.2 28.0 ± 3.1

Gravidity (number) 1.5 ± 0.6 1.5 ± 0.6

Parity (number) 1.0 ± 0.2 1.0 ± 0.2

Education No. of subjects (%) No. of subjects (%)

0-6 years 199 (30.1) 316 (31.9)

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 7-9 years 212 (32.0) 297 (29.9)

10-12 years 132 (19.9) 198 (20.0)

>12 years 119 (18.0) 181 (18.2)

Occupation No. of subjects (%) No. of subjects (%)

Peasant 403 (60.9) 626 (63.1)

Labourer 154 (23.2) 216 (21.8)

Intellectual 105 (15.9) 150 (15.1)

3. Acceptability

Due to its high efficacy, low expenditure and extreme safety incomparable by any other contraceptive methods, the BOM
is well accepted by the Chinese couple of different cultural and economical backgrounds.5-7 Lower reproductive tract
infection (vaginitis and cervicitis), quite common in the low cultural stratum in China, does not influence the observation
of the mucus symptoms.

It is interesting to note that in one field trial, most failure cases had a relatively high cultural level (two university
graduates and two lecturers). They all felt sorry and admitted that since they considered the method was simple and easy
to master, they had paid less attention to the teaching course and had not strictly followed the rules. The consequence
was use-related failures. On the contrary, the illiterate women were generally very attentive to BOM teaching and rigidly
stuck to the rules, and failures were very rare. This experience gives us the following elicitation:

3.1 The BOM is simple and easy to comprehend; almost all the women, including the illiterate, can successfully learn
the method and identify their own mucus symptoms.

3.2 During the training, special attention should be paid to the intellectuals and professionals. The method seems to be
too "simple" to them and they could not get hold of it without strict supervision.

Interim conclusion: BOM is well accepted and by the Chinese women of different cultural and economical
backgrounds; illiteracy and lower reproductive tract infection are not incompatible with the use of the Method.

4. Comparative Study on BOM and IUD

1,654 healthy women of proven fertility (having at least one live birth), aged 24-35 years, with regular menstrual cycles
(3-7/24-35 days), to be cohabiting and enjoying their husbands' support for participation in the trial, were enrolled. The
participants were mostly peasants and also workers and white collars with different educational levels (Table 1). They
were randomly divided according to the ratio 3: 2 into two groups (the BOM group, 992 subjects, and the IUD group, 662
subjects). The observation was continued for 12 months.

Results showed that in the BOM group five women became pregnant (all use-related), the pregnancy rate being 0.5%,
while in the IUD group there were 12 pregnancies (2%), the difference being highly significant (P < 0.01). From Table 2,
it was also seen that the discontinuation due to medical reasons was significantly lower (P < 0.001) in the BOM than in
the IUD group. Besides, in the IUD group, there were 15 expulsions and 38 removals due to severe pain/bleeding; thus
the total use-related discontinuations amounted to 65 cases (12 pregnancies, 15 expulsions and 38 medical
removals). Nothing particular was seen in the BOM group and only five pregnant cases were medically discontinued.

Table 2. Gross cumulative 12-month life table (Tietze) event rates (per 100 women)

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 BOM IUD
P
(rate ± S.E.) (rate ± S.E.)

Pregnancy 0.5 ± 0.2 2.0 ± 0.6 <0.01

Expulsion 2.6 ± 0.7

Medical removal 6.3 ± 1.0

Use-related discontinuations 0.5 ± 0.2 10.6 ± 1.2 <0.001

Non-medical discontinuations 3.1 ± 0.9 0.5 ± 0.3

Loss to follow-up 1.0 ± 0.3 1.1 ± 0.3

Continuation rate 96.4 ± 0.6 89.3 ± 1.2 <0.01

Continuation: case number 966 587

Women-months of use 9,870 6,299

Total number of cases 992 662

5. Achieving Pregnancy

The BOM has also been employed widely in many Infertility Clinics in China to achieve pregnancy. Women wishing to
be pregnant were subject to a brief training course, the main purpose of which was to identify the fertile days, the Peak
and the BIP. The BIP (Basic Infertile Pattern) enables the woman to define days of infertility before the fertile phase
begins. Besides, teachers would help them to determine the days for centralized intercourse. The schemed intercourse
protocol was as follows: (1) during the BIP, intercourse every 3 days or more in order to clearly identify the mucus
symptoms and to reserve enough sperm for the fertile days; (2) during the fertile days, intercourse every other day in order
to identify the elapse of the fertile phase and to reserve more sperm for the next intercourse; (3) no more restrictions on
the days after the Peak.

According to an incomplete survey, in 3,268 couples using the BOM for infertility without apparent cause, 1,032 got live
babies after 2-5 cycles, the live baby rate being 31.6%. Many couples had been infertile for more than 5 years, and
became pregnant after the schemed intercourse. The people affectionately called these babies the Billings babies and the
doctors in charge of the Billings Infertility Clinics (established in many localities in China) have been given the title of
Baby-Provider by the common folk.

Interim conclusion: the BOM is effective in achieving pregnancy in infertile couples.

6. Conclusion

6.1 The BOM is well accepted and by the Chinese women of different cultural and economical backgrounds; illiteracy
and lower reproductive tract infection are not incompatible with the use of the method.

6.2 The use-effectiveness of the BOM is much higher than that of TCu220c, one of the most popular IUDs used in
China.

6.3 The BOM is effective in achieving pregnancy in Chinese infertile couples.

References

1. Billings, J. J. (1983). The Ovulation Method, 7th Edn. [Ovulation Method Research and Reference Centre of Australia :Melbourne.]

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2. Billings, E. L., Billings, J. J., Brown J. B., and Burger, H.G. (1972). "Symptoms and hormonal changes accompanying ovulation",
Lancet i, 282.

3. Billings, E. L., Billings, J. J., and Catarinich, M. (1989). Billings Atlas of the Ovulation Method, 5th Edn. [Ovulation Method Research
and Reference Centre of Australia : Melbourne.]

4. Billings, E. L., and Westmore, A. (1997). The Billings Method : Controlling Fertility without Drugs or Devices, 3rd Edn., 2nd Revision
2000. [Anne O’Donovan Press: Melbourne.]

5. World Health Organization (1981). "A prospective multicentre trial of the ovulation method of natural family planning. II. The
effectiveness phase", Fertil. Steril. 36, 591–8.

6. Indian Council on Medical Research Task Force on Family Planning. (1996), "Field trial of the Billings ovulation method",
Contraception 53, 69–74.

7. Weissman, M. C., Foliaki, L., Billings, E. L., and Billings, J. J. (1972), "A trial of the ovulation method of family planning in Tonga",
Lancet i, 813.

8. Ball. M. (1976), "A prospective field trial of the ovulation method for avoiding conception", Eur. J. Obstet. Reprod. Biol. 6, 63.

9. Dolack, L. (1978), "Study confirms values of ovulation method", Hosp. Prog. 59, 64.

10. Klaus, H., Goebel, J. M., Muraski, B., et al. (1979), "Use-effectiveness and client satisfaction in six centers teaching the BOM",
Contraception 19, 613.

11. Wade, M. E., McCarthy, P., Abernathy, J. R., et al. (1979), "A randomized prospective study of the use-effectiveness of two
methods of natural family planning: an interim report", Am. J. Obstet. Gynecol. 134, 628.

12. Xu, J. H., Yan, J. H., Fan, D. Z., and Zhang, D. W. (1990), "A preliminary report on the application of the Billings ovulation method
for fertility regulation in Shanghai", Reprod. Contracep. (China) 10(2),53-6.

13. Xu, J. H., Yan, J. H., Fan, D. Z., et al. (1993), "Clinical effectiveness and laboratory study of the Billings ovulation method in 688
couples in Shanghai", Reprod. Contracep. (China) 13, 194–200.

14. Qian, S. Z. (1999), "Natural fertility regulation", in Reproductive Health, Eds. S.G. Gu et al. [People’s Publishing House : Beijing.]

15. Dou, F. B., Zuo, H. Z., and Qian, S. Z. (1996), "Physiological consideration of natural fertility regulation", J. Prac. Androl. (China) 2,
196–8.

16. Zuo, H. Z., Dou, F. B., and Qian, S. Z. (1997), "Introduction to natural fertility regulation", Reprod.
Contracep. (China) 17, 188–90.

Effectiveness of Billings Ovulation Method™ in Avoiding Pregnancy

Fertility control should be reliable, harmless, immediately reversible, and inexpensive. It should not detract from the
pleasure of sexual intercourse and it should encourage a good emotional and sexual relationship between partners. Many
women find the various methods of contraception available to be unsatisfactory or unacceptable.
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In practice every known method of fertility control has a failure rate. Some methods have a significantly lower failure rate
than others. The Billings Ovulation Method™ has been independently trialled by the World Health Organisation and other
reputable bodies and been found to be as successful for avoiding pregnancy as any method of family planning available
today. It has the distinct advantage of also being able to be used to assist a couple to achieve a desired pregnancy.

Since the 1970's, trials of the Billings Ovulation Method™ have been carried out in every decade in countries as diverse as
Australia, Korea, India, Ireland, USA, Africa, Indonesia, the Philippines, El Salvador, New Zealand and China.

From the earliest trials, method-related pregnancy rates were as low as 0 to 4 per cent. As teaching methods were refined
and updated, these rates fell close to zero. Continuation rates were consistently high.

It is generally accepted that acquisition of accurate knowledge of the Billings Ovulation Method™ by the couple,
combined with motivation and co-operation ensure success.

One of the largest trials, a 12-month multi-centre study in China which included couples of different social/education
status in rural and urban China, considered the effectiveness of the Method in avoiding pregnancy when compared with the
IUD and the combined use of the Billings Ovulation Method™ and the IUD. The method-related pregnancy rate of the
Billings Ovulation Method™ user group was zero and their continuation rate was significantly higher than those in the
IUD group.

The trials continue to show low levels of pregnancies attributable to faults in the Billings Ovulation Method™. It was
demonstrated that the Method is applicable to all phases of reproductive life, beneficial in the solution of seeming
infertility and useful in diagnosing reproductive abnormalities.

The most common cause of pregnancy is the couple’s decision to have a baby, which knowledge of the fertile signs readily
enables them to do.

The benefits of the Billings Ovulation Method™ go far beyond accuracy in regulating fertility. The need to become aware
of the signs of natural fertility and infertility adds another dimension to the relationship between the couple as they agree
to wait without intercourse for a few days, when the woman recognises that she is potentially fertile, in order to achieve
their aim for fertility control. The bond between them strengthens and the family becomes stable and secure. Rather than
something that ‘just happens’ between them, the physical sexual relationship becomes part of a powerful communication,
with times of abstinence being another way of declaring their love for each other and their family.

Billings LIFE - Leaders in Fertility Education

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