RESPONSE TO QUERIES RELATED TO REPRODUCTIVE HEALTH BILLS AS REQUESTED BY HON. EDCEL C.

LAGMAN, Representative, 1st District of Albay

World Health Organization Philippines

17 January 2011

The House of Representatives Committee on Population and Family Relations requested answers to the following queries from the World Health Organization (WHO) Philippines in relation to the public hearings being conducted on the six versions of the Reproductive Health Bills filed before the 15th Congress. The request was dated 14 December 2010 from Hon. Edcel C. Lagman, Minority Leader. The WHO Country Office forwarded this request to the WHO Headquarters in Geneva. The questions to be addressed are the following: 1. 2. 3. 4. 5. 6. 7. 8. 9. What is the medical definition of pregnancy? Is pregnancy synonymous with fertilization? Is pregnancy synonymous with conception? Is a fertilized ovum viable in the absence of implantation in the uterus? What is the medical definition of abortion? Are contraceptives like pills, injectables and IUDs capable of terminating an existing pregnancy? What are the mechanisms of action of the above contraceptives? Is there any hard evidence to prove the hypothesis that hormonal contraceptives can prevent the implantation of a fertilized egg? How does lactational amenorrhea work? Will LAM produce physiological changes in the uterine lining that may prevent the implantation of a fertilized egg?

1. What is the medical definition of pregnancy? There are several medical, or clinical definitions of pregnancy, including clinical signs and symptoms, and laboratory or ultrasound determination. A laboratory pregnancy refers to either by a serum or urine determination of levels of the Human Chorionic Gonadotropin Hormone (HCG) which can be elevated few days after implantation when the trophoblastic cells would have started to produce HCG. An ultrasound would detect pregnancy much later, at approximately 5 to 6 weeks. A woman can start feeling fetal movements at around 20 weeks age of gestation. 2. Is pregnancy synonymous with fertilization? Fertilization is considered part of a long process of activities that result in a pregnancy. In reality no one can actually determine the exact time fertilization occurs in a woman, nor if it actually occurs. Not all fertilization leads into embryo development, or into implantation, or into pregnancy. Natural losses take place along the way. 3. Is pregnancy synonymous with conception?

The term "conception" is commonly used interchangeably with "fertilization." Please refer to item 2 above. 4. Is a fertilized ovum viable in the absence of implantation in the uterus? No. There is a very limited amount of metabolic support in a fertilized human egg, with hardly any contribution from the sperm. Because of its limited amount, it needs to be implanted. Even in the best circumstances, not all fertilized eggs even implant. 5. What is the medical definition of abortion? The medical or clinical definition of abortion is the termination of pregnancy before a fetus is considered viable. The definition of "viability" varies according to several factors particular to each setting. 6. Are contraceptives like pills, injectables and IUDs capable of terminating an existing pregnancy? The present evidence on the mechanism of action of contraceptive pills and injectables is the prevention of ovulation. Thus, these do not have a terminating effect on an implanted ovum, as there is no fertilized ovum or even an ovum to fertilize, to begin with. Current evidence also demonstrates that there is no effect by contraceptive pills or other hormonal contraceptives on an already implanted fertilized ovum. Studies on recovery of eggs from women using copper-bearing IUDs and from women not using any method of contraception show that rates of embryo formation in the tubes are much lower in copperbearing IUD users than those not using contraception (Alvarez et al. 1988). Thus, the hypothesis that the primary mechanism of copperbearing IUDs in women is destruction of embryos in the uterus (i.e., abortion) is not supported by available evidence. When used appropriately by adequately trained staff, an IUD does not cause abortion, as it is not going to be inserted unless it is certain that the woman is not pregnant. 7. What are the mechanisms of action of the above contraceptives? The mechanisms of action of the contraceptive drugs and devices are as follows: a. Combined Hormonal Methods (oral contraceptives and Evra patch): There has been a growing body of evidence for more than four decades indicating that administration of combined oral contraceptives (COC) inhibits follicular 3

development and ovulation, and that this is their primary mechanism of action (Mishell et al. 1977; Killick et al. 1987; Rivera et al. 1999). They also affect cervical mucus, making it thicker and more difficult for sperm to penetrate. This effect may also contribute to their high efficacy (Rivera et al. 1999). Although it is known that there are changes in the endometrium during combined oral contraceptive (COC) use, no evidence to date has supported the hypothesis that these changes lead to disruption of implantation. Given the high efficacy of COCs in preventing ovulation, it is very unlikely that "interference with implantation" is a "primary mechanism" of contraceptive action. The same mechanism of action also applies to the Evra patch. b. Progestin-only Methods (Depo Provera, minipills, implants): Progestin-only methods also inhibit follicular development and ovulation although the level of this effect varies for different progestin-only methods and among individuals. For Depo Provera, the level of ovarian suppression is very high; therefore inhibition of ovulation is the primary mechanism of action (Rivera et al. 1999). However, about 40% of women on the minipill may ovulate (Landgren and Diczfalusy 1980). A second contraceptive effect of progestin-only methods is the change they make to cervical mucus, including increasing its viscosity and cell content, reducing its volume, and altering its pH, proteins and molecular structure. This makes it "hostile" and impenetrable to sperm (Moghissi et al. 1973). These changes are likely to play a more important role in the mechanism of contraceptive action of minipills and implants. Progestin-only methods also cause changes in the endometrium. However, these changes show great variability among patients, from atrophy to normal secretory structures. There is no direct evidence that suggests a relationship between endometrial structure and contraceptive effectiveness of these methods. c. Emergency Contraception (morning-after pills, levonorgestrel, levonorgestrel 2): Levonorgestrel emergency contraceptive pills (ECPs) have been shown to prevent ovulation and they do not have any detectable effect on the endometrium (uterine lining) or progesterone levels when given after ovulation. ECPs are not effective once the process of implantation has begun, and will not cause abortion (WHO 2005; Marions L et al. 2002; Durand M et al. 2001; Croxatto HB et al. 2004). 4

d. Intrauterine Devices (IUD): The major effect of all IUDs is to induce a local inflammatory reaction in the uterine cavity. During the use of copper-releasing IUDs the reaction is enhanced by the release of copper ions into the luminal fluids of the genital tract, which is toxic to sperm (Ortiz 1978; Seseru and CarnachoOrtega 1972; Ullman and Hammerstein 1972). In these users, it is likely that few sperm reach the tubes and those that do reach them have low fertilizing power. These contraceptive drugs and devices fulfil WHO's evidencebased international standards on the mechanisms of action and are included in the WHO Model List of Essential Medicines (2005). 8. Is there any hard evidence to prove the hypothesis that hormonal contraceptives can prevent the implantation of a fertilized egg? Combined hormonal methods directly or indirectly have effects on the endometrium that may hypothetically prevent implantation, however there is no scientific evidence supporting this possibility. When used appropriately and in doses/ways recommended, none of these methods have been shown to cause the abortion of an implanted fetus. 9. How does lactational amenorrhea work? Will LAM produce physiological changes in the uterine lining that may prevent the implantation of a fertilized egg? Lactational amenorrhea works by a series of physiological hormonal events which leads to prevention of ovulation, as a result of the presence of hormones that promote lactation. No uterine effects are found in LAM. There would not be fertilized eggs because there would not be any eggs released.