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GyneFix

 Copper-bearing IUD, not hormonal.

GyneFix is revolutionary in its conception:

  • It is very small in size – 1/6 of the regular IUD.
  • It fastens to the uterine wall, and is positioned more stably as compared to other IUDs.
  • It is suitable for any uterus shape.
  • Its shape is better tolerated, it causes less increase in menstrual bleeding and fewer bleedings in between cycles (3% of insertions).
  • Its insertion requires the dortor to have special skills

It is as effective as regular IUDs.


The full article:

 

Studies of the uterus have shown that it is not easy to design a universal IUD.  Indeed uterine cavities differ considerably in all women.  The uterus is also subject to changes in size and volume during the menstrual cycle.  These changes are most pronounced at the time of the menstrual period.  It is therefore unreasonable to expect one standard sized intrauterine device (IUD) to fit uterine cavities of every different sizes and volume.  IUDs that are much bigger, or much smaller than the uterine cavity can cause problems.  If the width of the uterine cavity is too small, side effects and complications are likely to occur.  The crossarms of standard T-shaped IUDs are frequently too long for a large number of uterine cavities, as the average width of most uterine cavities is often smaller than the width of the IUD itself.  When the uterine cavity is much longer than the IUD, the device becomes partly or completely lodged in the lower uterine isthmic segment, triggering uterine activity that may promote explusion and give rise to pain.

Prof. Howard Tatum, inventor of the standard T-shaped IUD:  “The most important factor in reducing IUD side effects is the elimination of distortion of the uterine cavity”
(Verbal presentation at the 4th Congress of the European Society of Contraception, Barcelona, 12-15 June 1996)

To reduce side effects and maximise tolerance, women should be fitted with an IUD which causes no or minimal distortion of the uterine cavity. The realtionship between the IUD and the uterine cavity is optimal with the frameless GyneFix® IUD.

 

G A Revolutionary IUD Concept


Minimizing the size
of the intrauterine foreign body

 



 

GyneFix® standard 
(in situ) 

GyneFix® standard
compared with
TCu380A (Gravigard®)  

and Multiload® (ML) Cu375 IUD.

 

Three generations of IUDs:
GyneFix
® mini is the
smallest IUD ever developed

 










 

1960s
: The Lippes Loop,  developed in the 1960s
resulted directly from
the invention of thermoplastics.

 1980s: The TCu380A or  Paragard® seemed a logical  design
which would cause a  minimum of distortion
of  the endometrial
cavity.

2003: The total surface area of the GyneFix®
mini is three times
lower than TCu380A and six times lower than the Lippes Loop. The anchored, frameless and flexible, GyneFix
® mini IUD was developed to improve performance and enhance
acceptability of intrauterine contraception.

The unique string
shaped
GyneFix
® IUD occupies
little space in the
uterine cavity and is therefore able
to fit cavities of every size.

GyneFix®
performance

The following summary is based on large-scale, long term international multicenter randomised and non-randomised comparative studies in parous and nulliparous women covering over 20,000 woman-years of experience:

HIGHLY EFFECTIVE

GyneFix® is a highly effective IUD.  The use effectiveness of GyneFix® is higher than that found with older generation ‘high-load’ conventional copper IUDs such as TCu380A (See Reviewers’ conclusions: O'Brien PA, Marfleet C. Frameless Versus Classical Intrauterine Device for Contraception. The Cochrane Library, Issue 4, 2001).  The high initial and ongoing effectiveness of the GyneFix® ‘anchored device’ is attributed to its constant and optimal release of spermicidal copper ions in the upper part of the uterine cavity. Of importance is that ectopic pregnancies almost never occur with GyneFix®. In this respect, GyneFix® is superior to the TCu380A (World Health Organisation 10-year follow-up data). Three year multicentre clinical studies with GyneFix® mini suggest that this small version has a similar efficacy as the standard GyneFix®.

LOW EXPULSION

When properly inserted, spontaneous expulsion of the GyneFix® frameless IUD occurs in less than 1% of women during a 5-year period of use.  With older generation ‘framed’ IUDs this incidence has been variously reported, but is on average 5 to 10 times higher, particularly in nulliparous women. As displacement and partial or total expulsion is the main reason for the occurrence of accidental pregnancy, the GyneFix® is a major step forward in this respect.

OPTIMAL TOLERANCE

As GyneFix® is ‘frameless’ it is also extremely flexible.  This explains the very low incidence of side effects and complications.  Complaints of pain occur only infrequently with GyneFix® as its novel design characteristics allow the device to move in harmony with the wearer’s body.
Abnormal bleeding occurs in few women and results from the wearer’s sensitivity to copper.  Medication such as anti-fibrinolytic agents, non-steroid anti-inflammatory drugs have been shown to be helpful in some cases. GyneFix® mini does not increase blood loss (see below) due to its small size.

Advantages of the
"frameless" 
copper-releasing

Parous as well as
nulliparous
women have been
highly
satisfied with
the use of GyneFix®.

When properly inserted,
the frameless IUD offers
several important
advantages:

  • High efficacy

  • Efficacy does
    not decrease
    with time

  • Low expulsion rate

  • Reduced bleeding

  • Reduced pain
    complaints

  • Long duration
    of action

Some comments on abnormal bleeding and pain : the main reason for IUD removal

BLEEDING

Increased menstrual blood loss is the main reason for discontinuing the use of IUDs. The magnitude of this increase in menstrual blood loss is related to the size of the device.  With larger types of  non-medicated IUD such as the Lippes Loop, the blood loss is about 70-80 mL, which is  approximately twice that of normal menses.  The amount of excess bleeding is less (50-60 mL) with the smaller copper devices such as the copper T series. Clinical trials demonstrate that particularly the small GyneFix® version reduces the incidence of heavy blood loss due to the small size of the foreign body. Menstrual blood loss studies suggest that the small GyneFix® does not increase menstrual blood loss when compared to the period prior to IUD use. 
The frameless GyneFix®, although providing progress in terms of contraceptive performance and patient acceptability, does not itself reduce menstrual bleeding. This can be achieved by delivering intrauterine progestins (Click here for Contrel Research section).

PAIN

GyneFix® rarely causes complaints of pain due to its small size and flexibility.  With conventional "framed" copper IUDs, incompatibility between the device and the endometrial cavity often causes myometrial distension of the uterus.  Depending on the degree of the disharmony, severe cramping pain can be caused resulting in abnormal bleeding and partial or complete expulsion of the IUD.

Other important features of GyneFix®

GyneFix®


in nulliparous women 
 
Fallacies exist about intrauterine devices - most commonly that they can only be used by women who have already had children.  This is not the case with GyneFix® as it adapts to any uterus, even the smaller uterine cavities of women with no children.
When GyneFix® has been used in teenagers it has been found to be as effective and acceptable as in older women.
GyneFix® does not offer protection against sexual transmitted infections (STIs) such as chlamydia, HIV or hepatitis B.  It is therefore not recommended for women likely to have constantly changing sexual relationships, unless used in conjunction with condoms.

GyneFix® mini should be the preferred option in nulliparous women.

GyneFix® AS AN EMERGENCY CONTRACEPTIVE
GyneFix® is particularly useful in emergency contraception because it can be inserted up to 5 days after unprotected intercourse, and will then provide ongoing contraception.  Women requesting emergency contraception tend to be young and have no children.  GyneFix®  is a good choice for these women, provided they are at low risk of STIs.
IUDs are more effective in preventing unwanted pregnancy than emergency pills.  Pills prevent approximately 3 out of 4 pregnancies, and need to be taken within 72 hours. In contrast hardly any failures have ever been reported when using emergency IUDs.

GyneFix® FOR IMMEDIATE POST-ABORTAL  
GyneFix® could constitute an important new option in the prevention of repeat abortion.  In countries like the UK, France and Italy the number of abortions carried out annually is close to 200,000.  This number is much higher in Eastern European and developing countries.  In many countries over 50% of abortions are carried out in women under 25 years old.
Traditional IUDs are more likely to fall out if inserted at the time of a termination of pregnancy.  Their insertion is therefore usually delayed, requiring another visit by the woman and exposing her to a risk of further pregnancy.  However, GyneFix® with it’s unique secure anchoring system can be fitted immediatly.

GyneFix® AS AN ALTERNATIVE FOR STERILISATION
In the world today, many women rely on sterilisation of one or other partner to prevent pregnancy. However, many couples would prefer to avoid surgery.  The main drawback of sterilisation is that it is difficult to reverse without futher surgery.  Published figures show that up to 20% of sterilised women in the United States of America request a reversal operation, the results of which are not predictable.
GyneFix® offers an alternative, long term, effective option.

 

 

 

 

Intra-Uterine Device (IUD)

The IUD is a small plastic device, with the addition of copper, which is inserted into the uterine cavity. It is adequate for use for different periods of time, from 1/2 a year to 5 years. 
Its effectiveness is over 99%.

Usage Instructions:

The IUD may be inserted only by a skilled Gynecologist. The doctor inserts the IUD into the uterus through the cervix.
It is recommended to insert the IUD during menstruation for the following reasons:

  1. The insertion of the IUD provokes bleeding, so the woman won't bleed twice.

  2. The Cervix is dilated during menstruation, hence facilitating the insertion of the IUD.

  3. It is conclusive that the woman is not pregnant.

However, it is possible to insert an IUD at any time, provided it is certain there is no pregnancy. 
The strings attached to the IUD are left in the vagina in order to facilitate its extraction when the time comes. 
The insertion takes a couple of minutes and is painless. The woman may feel some discomfort for the following 2 or 3 days.

Method of contraception:

The IUD works in two ways:

  1. The main mechanism: it disturbs the spermatozoon's movements in the cervical mucous, impedes its reaching the uterus and hence prevents the fertilization of the ovule.

  2. Secondary mechanism: it prevents the ovum from rooting in the uterine membrane.

Anti-inflammatory medications such as Aspirin, Cortisone, Voltarene, Advil, Ibuprophen, etc., may somewhat diminish its effectiveness, hence a spermicide should be used during intercourse for a week after consuming the last pill or after using anti-inflammatory ointments or gel.
Medications such as Acamol, Optalgin, and Antibiotics don't affect the IUD's effectiveness.

For whom is the IUD suitable?

* The use of an IUD requires the referral of a doctor after examination.

Usually, the IUD is recommended for:

  • Women who have given birth.

  • Women who are engaged in a permanent relationship.

  • Women who are not interested in getting pregnant for a long period of time (at least 6 months).

Who is usually advised not to use an IUD?

  • Women who have not yet given birth.

  • Women who have suffered uterine infections.

  • Women who are not engaged in a permanent relationship.

  • Women who bleed heavily during menstruation.

  • Women who suffer anemia.

  • Women who take anti-coagulation medication (i.e. aspirin, coumadin).

All these conditions don't necessarily prevent the usage of an IUD, therefore the specialist will consider each case individually, in order to provide the best and most appropriate advice.

Problems which may arise while using an IUD:

  • Insertion of the IUD increases the risk of infection in the pelvic cavity during the first 20 days after insertion (high fever, severe pain in the low abdomen, secretions). This risk is decreased in married women, in those who have a regular partner and in women who observe the "Tahara" laws (in these women, intercourse takes place at a time, distantly removed from the menstrual period, decreasing the risk of infection).

  • In case of a fever, pain or heavy discharge, the woman must seek the help of a gynecologist urgently, in order to verify the diagnosis and begin antibiotic treatment right away and/or remove the IUD.

  • Rarely, pregnancy may occur in spite of the presence of an IUD. In this case, there is a risk of a natural or infectious miscarriage. For this reason one should try to have the IUD removed immediately. The removal of an IUD does not, in most cases, induce a miscarriage.

  • In very rare cases the IUD may damage the uterine wall perforating it into the abdominal cavity. Performing an Ultra Sound before and after the insertion of the IUD, and having the insertion performed by a skilled gynecologist, minimizes this risk to very rare.

Advantages:

  • Very high effectiveness and lack of hormonal influence, leaving the woman with her personal hormonal balance and with her spontaneous cycle.

  • It decreases the risk of ectopic pregnancies by 20-30, in comparison to women who do not use any means of contraception.
    In other words, a woman who does not use any contraceptive and who does not have an IUD, carries a higher risk, by 20-30, of an ectopic pregnancy.

Disadvantages:

  • In about 7% of women, the IUD may cause bleeding between cycles.
  • The IUD may cause heavier and longer bleeding periods as well as greater sensitivity during menstruation.
  • Gynefix reduces significantly the occurrence of bleeding between cycles.
  • Gynefix increases menstrual bleeding as do all other IUDs, but less so than any other copper IUD and is better tolerated than any other IUD because of its delicateness.

Sponse

To be used as a disposable device only.

The sponge blocks the passage way from the vagina to the uterus and exterminates within it the spermatozoa by means of the spermicide in it.
Its effectiveness lies between 85-90%.

Usage Instructions:

  1. When opening the package one should check whether the sponge is soft or hard. If it is hard it should not be used.

  2. The sponge should be introduced into the vagina like a tampon until it is placed at the opening of the cervix.

  3. The sponge may be left in place for 24 hours. The couple may have intercourse as many times as they wish during this time.

  4. The sponge should be removed 6 hrs. after the last sexual contact.

  5. The sponge should not be left in the vagina for more than 30 hrs.

Advantages:

  • May be purchased over the counter.

  • Accessible and easy to use.

  • It may be inserted into the vagina several hours before intercourse, it may be left in place for 24 hrs. and it is effective immediately upon insertion.

  • The spermicide in the sponge also helps prevent certain venereal diseases.

Disadvantages:

  • Its effectiveness is low in comparison to other contraceptives.
  • It is sometimes difficult to remove (in such cases one should push like when going to the bathroom).
  • If the sponge moves and is not leaning against the cervix, its effectiveness decreases.
  • The spermicide may cause some irritation.

Spermicides

Spermicides are chemical substances which kill the spermatozoa.

They appear in different forms, such as ointment, gel, pills, foam to be injected into the vagina, chemicals to be dissolved in the vagina just as any pill will dissolve after ingestion. For this reason a lapse of 10-20 minutes should be allowed before beginning sexual intercourse.

Their effectiveness reaches up to 80%.

Spermicides are not recommended to be used alone as a means of contraception, unless the woman is still fully breast feeding and has still not had her period after giving birth.

They are usually used in addition to the Diaphragm.











 

Diaphragm

  1. The diaphragm blocks the passage of sperm from the vagina into the uterus.

  2. The diaphragm comes in different sizes and the right size may be determined only through examination by the gynecologist.

  3. Every once in a while the rubber of the diaphragm should be checked for holes and loss of elasticity.

  4. Should there be a change in weight (±5 Kg or more) or after giving birth, an examination by a gynecologist should be performed to check for changes in the size of the cervix, which would require a different size of diaphragm.

Effectiveness 85%-92%.

Usage Instructions

  1. A spermicidal cream should be spread over both sides of the diaphragm.

  2. The diaphragm is introduced into the vagina and set around the cervix. When positioned correctly, the diaphragm should not be felt during intercourse.

  3. The diaphragm may be inserted up to 2 hours before intercourse.

  4. After intercourse, the diaphragm should be left in place 6-8 hours before removal.

  5. Before removing the diaphragm, if intercourse is desired again, an additional amount of spermicide should be inserted into the vagina.

  6. The diaphragm should not be left in the vagina for more than 24 hours.

  7. If discomfort is felt in the vagina, the diaphragm is not positioned correctly.

  8. After removal, the diaphragm should be washed in warm water and soap and returned to its container.

Advantages

  • It may be inserted up to two hours before intercourse.

  • It prevents some venereal diseases.

  • It is available and easy to use.

  • It is easy to store.

  • It is not disposable and can be re-used.

Disadvantages

  • Its effectiveness is relatively low.

  • A gynecologist must examine for suitability and measurement.

  • It must be left in place for 6-8 hours after intercourse.

  • There is sometimes difficulty in insertion or removal.

  • There may be sensitivity to the rubber or the spermicidal.

 

Mirena

Hormonal IUD (Progestative).

Its effectiveness is over 99%.

The insertion method is identical to that of the copper-bearing IUD. The arms of the IUD extend across the cavity and lean on the sidewalls.

Its contraceptive action relies on the local influence of the Progesterone contained in its axis. The progesterone in turn, has the following causative effects

The cervical mucous thickens, preventing the spermatozoa from entering the uterine cavity.

There is a change in the lining of the uterus, reducing its capability to nest a pregnancy

The uterine lining becomes very thin, therefore the menstrual period shortens and bleeding is lighter.

It is advised to insert the Mirena IUD during menstruation or 6 weeks after birth or miscarriage.

Mirena is effective for 5 years, though it could be extracted earlier according to the woman's preference.

After the 5 year period, should the woman decided to continue using the same contraceptive method, the Mirena IUD may be replaced by a new one during the same visit to the doctor.

The most common side effects are irregular menstrual periods, unexpected bleeding, and lower abdomen contractions. Also, acne, congestion in the breasts, lower back pain, and sometimes increased secretions, headaches, decrease in sexual drive or depression, nausea, weight gain, excessive sweat, hair loss, greasy hair and swollen abdomen.

Mirena has no influence on hyper-coagulation disorders and reduces the risk for ectopic pregnancies in comparison to women who use no contraception.

The Mirena IUD should be extracted in case of pregnancy, pelvic inflammation or headache.

Women who observe the Tahara laws have great difficulty in performing the Hefsek Tahara for the first 3-6 months after insertion of the Mirena IUD. Because staining appears alternately in between cycles, they refrain from going to the Mikveh for long periods of time, and therefore give up on the IUD and ask to have it removed.

This disadvantage should be explained to the couple who observe the Tahara laws, explaining the fact that after a 3-6 month period. The menstrual periods will be short and light.

 

In 20% of cases total absence of menstruation may occur.

The Pill

Its effectiveness is over 99%.

The pill contains hormones which inhibit ovulation

Types of pill

In Israel, there are more than 20 different types of pills which contain different dosages of hormones.

Most packages contain 21 pills to be taken each day, followed by a 7 day break.

There are different forms of use

  1. Stickers: The hormones pass through the skin. The sticker is replaced once a week for three weeks (3 stickers), followed by a 7 day break.
  2. Birth control ring (Nuva Ring): inserted into the vagina and removed after 21 days followed by a 7 day break.

Usage Instructions

  1. The first pill should be taken on the first day of menstruation.
  2. A pill should be taken each day, preferably more or less at the same time.
  3. After taking 21 pills, a break of 7 days should be made. Menstruation should occur during this week (usually after two days).
  4. After the week break, without consideration of whether menstruation began or ended, a new package should be started (in this manner, the first pill will always be taken at the same day of the week).
* If a pill is forgotten and more than 24 hrs. have passed, then 2 pills should be taken together. Other than this, a physician should be consulted. You should take the pill the moment you noticed that you forgot (do not skip a pill), the rest of the pills should be taken at the regular time daily. If you skipped a pill, take notice! You must use a backup means of contraception such as a local blocker, spermicide, or sponge, or refrain from any sexual contact for 7 days.
 

Side effects when using the Pill

There is a long list of possible side effects: from mood swings and lack of sexual drive to more serious illnesses, therefore you should consult your gynecologist for the most suitable means of contraception for you.

The most common side effects are

When beginning to use the Pill, the first pill is taken with the first day of menstruation, it could be that bleeding stops or that bleeding continues longer than usual. With the second package these symptoms usually disappears.
  1. Light bleeding may occur half way through the package.
  2. Breast tenderness.
  3. Increased vaginal secretions (first three months).
These side effects may be unpleasant, however they do not affect your health. They may subside after the first or second package. Should the side effects continue, a gynecologist should be consulted.
 

Uncommon side effects which require immediate medical consultation

Strong pain in the legs.
Difficulty breathing.
Strong head aches (migraines).
Difficulty with eye sight.
Dizziness or fainting feeling.
These symptoms are rare, but require immediate medical intervention.
It is not advised to discontinue the Pill on your own.

As of when is the Pill effective in preventing pregnancy ?

Immediately – provided you begin taking the pill with the first day of menstruation.

Situations in which the Pill is not effective or is less effective

  1. The woman is not protected against pregnancy during the first two weeks after beginning taking the Pill (for the first time) by the fifth day of menstruation (there are a few brands of Pill for which the manufacturer advises to begin by the fifth day of menstruation).
  2. When taking the Pill for the first time, if a Pill is forgotten (for more than 12 hours after the regular time), pregnancy is possible, therefore a local contraceptive should be used for two weeks or consider using the "Morning-after Pill".
  3. A gynecologist should be consulted.
  4. Antibiotics may reduce the Pills effectiveness, therefore while taking antibiotics and until the next menstrual period, a local contraceptive should be used.
When vomiting or diarrhea occurs within 6 hours of taking the pill, an additional pill should be taken. The first pill was not absorbed into the body and it is as if it was not taken.

This problem does not occur with the sticker or the contraceptive ring.

Morning After Pill

In the case of unprotected intercourse, or in case the Pill was forgotten, an emergency contraceptive such as the morning-after Pill may be used, during the first 72 hours after intercourse or an IUD may be inserted within 5 days of intercourse.

What is it ?

Contraceptive Pills in high dosage.

How should it be used ?

You take a pill and 12 hours later you take another pill, and that is all! It is advised to take one regular contraceptive pill every day thereafter until a blood test for pregnancy is performed.

The Pills should be taken up to 72 hours after intercourse. It is better to begin as soon as possible to benefit from its full effectiveness.

How do the pills prevent pregnancy ?

  1. The pills cause a change in the uterine mucous so that the fertilized ovule cannot nest in it.
  2. The pills may delay ovulation.

Their effectiveness is high, but not 100%.

Side effects

In up to 50% of cases nausea will occur.
In up to 20% of cases vomiting will occur.
It is advised to eat before taking the pills.
The morning-after pill is an effective and medically safe contraceptive in some cases. At the same time, this is not an alternative for other regular effective contraception methods.

If more than 72 hours have gone by, an IUD may be inserted for up to 5 days after intercourse and then removed with the next menstruation or left in site as per the woman and her doctor's common decision.

Safe Days Method

Many people believe there are certain days during which it is completely safe to have intercourse without the risk of pregnancy.

There are those who believe these days to be around menstruation and away from ovulation time, therefore to have intercourse before menstruation or to postpone the Mikveh are safe natural methods to avoid pregnancy. But, since it is impossible to predict the exact day on which ovulation will occur or when the next menstrual period will begin, it is impossible to rely on this method!

Ovulation is the process through which the ovule in the ovary matures and exits into the fallopian tube. In order to get pregnant ovulation must take place. Since we don't know when ovulation begins, we cannot be sure when it is safe to have intercourse without getting pregnant. In addition, sperm can be in the woman's body for up to 5 days, even if intercourse took place when ovulation had not happened yet, if ovulation occurs within these five days you can still get pregnant.

Especially in young women, who's cycle is not regular, it is impossible to calculate the safe days. There are cases in which ovulation occurs right after menstruation, actually there is no day which is 100% secure, even if you use the "natural combined method". This method includes body temperature measuring, examination of cervical secretions, and the meticulous tracking of the menstrual cycle for 6 months. This method requires discipline and consistency; actually women who want to get pregnant use this method.

This method is less effective in preventing pregnancies.

There is notion that a woman ovulates on the 14th day after the first day of menstruation, but this is wrong. Ovulation is related to the length of the woman's menstrual cycle (the number of days from menstruation to menstruation). A woman ovulates, in average, 14 days before the next menstrual period. Since menstruation does not occur regularly like a clock, should menstruation happen earlier or later the ovulation day would change. Since it is impossible to predict exactly when a woman will have her next menstrual period, it is impossible to verify exactly when ovulation will begin.

Therefore, it is impossible to calculate with certainty during which days pregnancy will not occur.

 

          

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