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Clomiphene: An Optimal Alternative for Female Infertility

Female infertility is one of the most controversial issues in general. This is because for decades we considered that men were the real cause of the inability to procreate, but over time, we realized that this was a rather misconception.

Both men and women have sexual systems that are quite complex, and something can go wrong anywhere. Not only is there some anatomical alteration (such as a uterus with an altered internal environment), but also hormonal and functional alterations.

Just as technology has evolved over many years, so has the pharmaceutical industry. Not only have we been able to discover incredible discoveries hidden in the functioning of our bodies, but we have also been able to increase the options available to combat such delicate problems as infertility.

Clomiphene, without a doubt, is one of the best options available when it comes to increasing the probability of procreation. This drug is known as an "inducer" but only in women who do not ovulate or who ovulate very low frequency.

This drug is quite effective if there is no hormonal problem or, if not, the hypothalamic-pituitary-ovarian tract (in charge of directly regulating the female reproductive system) is in perfect condition. The idea is that clomiphene can produce ovulation and generate pregnant women.

Unlike other techniques, the risk of twin pregnancy is not so high, so it is rare to observe multiple gestations. Many times it can even be used as a diagnostic tool to corroborate that the woman has ovaries still in her reservoir. In addition, it can probably be used to regulate ovulatory cycles and increase the chances of artificial insemination treatments.

This drug is so useful that it may even increase sperm counts in male patients with reproductive disorders such as idiopathic oligospermia (one of the most common). Let us know a little more about Clomiphene and its potential on our body.

How does it work?

To science, clomiphene is classified as a selective estrogen receptor modulator (SERM), which in simpler words means that it can interact with the molecules in charge of perceiving and acting in the presence of estrogen.

Let's quickly understand the larger generalities of this reproductive system and the axis that controls it. In short, there are three organs that control the whole system: the hypothalamus, the pituitary and the ovary. These do so through hormones such as LH, FSH, progesterone, estrogen, etc. Each has an important and crucial function, but in addition, they function as messengers to each other.

FSH and LH levels can increase or inhibit the release of estrogen, and vice versa. It is a rather complex process that depends on the blood concentrations of each of these hormones, and it is this that gives life and function to the reproductive system.

However, where does clomiphene come in? Simple: it can block "negative feedback". Imagine that your ovaries already have enough hormones to function (from the pituitary gland), what does it do then? It sends a message to the hypothalamus to stop the cycle and decrease production.

What clomiphene does is it blocks that message. Now your hypothalamus is going to understand that there are still too few hormones and therefore it will increase the production of the mediators (or at least not limit it), which will cause your ovaries to continue working and nothing will stop them.

This will give the green light to the ovaries to produce the eggs and release them normally into the fallopian tubes. Of course, all the mediating hormones, such as FSH and LH, as well as the famous GnRH, are involved in this path.

The idea is that clomiphene allows "oocytes" (the involuted form) to develop into maturity in all women. Estrogen, which is a product of these developing follicles, will allow the endometrium (the inner layer of the uterus where the zygote is implanted) to proliferate. In addition, it will also encourage the expulsion of the egg itself from the already mature follicles.

Once ovulation occurs, the corpus luteum will form: a key piece of the normal hormonal cycle that allows the increase of progesterone, the true pregnancy hormone. This is what prepares the endometrium for implantation and improves all the necessary environmental conditions.

For this reason, clomiphene should be used early in the menstrual cycle, where it can only raise estrogen to promote ovulation, but does not alter progesterone production and the implantation of the zygote on the uterus. This is a rather delicate process that must be implemented by a specialist.

Usually the ideal time for the use of this drug is between day 5 and 9 of the menstrual cycle, which is known as the follicular phase. Women ovulate 5 to 10 days after the last dose of the clomiphene cycle, however, each body is different and special and personalized adaptations may be necessary.

It should be stressed that clomiphene itself is a weak estrogen agonist, so it can act (directly) on tissues that react to estrogen, such as the endometrium, vagina, cervix, and so on.

In the case of the cervix, it can alter the production capacity of cervical mucus, producing secretions that favor sperm mobility and, therefore, conception. On the other hand, in some women, this drug can cause dry, thick mucus that does not help the sperm to reach their destination.

There are many drugs that can interact with clomiphene, as we are talking about a specific hormone therapy that is useful for women with polycystic ovary syndrome. This is important because your specialist should be selective as to the drugs he or she will use in conjunction with this drug to improve possible adverse effects.

One of the most used adjuncts is octreotide, a fairly new drug that can decrease androgen secretion, LH levels and even the incidence of the famous ovarian hyperstimulation syndrome that often accompanies the use of clomiphene. Even so, it is necessary to emphasize that this is a drug for medical use, which must be monitored due to the various complications that may arise after its use.

For men with idiopathic oligospermia, where clomiphene has been shown to be effective, the mechanism of action is quite similar with the difference that the most important effect is at the level of the testicles, where testosterone and sperm production is increased. The volume and density increases, although it does not improve the quality of the sperm itself.

Pharmacokinetics: How Clomiphene Moves in Your Body

It is important for you to know that this drug is given orally and is very easily absorbed in both the stomach and the duodenum. Some of the compounds found in clomiphene (since it is a combination of several molecules) have different parameters that have not yet been well elucidated.

Both the drug itself and each of the metabolites that are produced are almost completely eliminated through the faeces, thanks to the bile. Sometimes part of the metabolites can accumulate inside our liver, but without representing any real problem since the plasma concentrations do not seem to exceed the permitted and safe limits. All this data, of course, is based on scientific evidence.

How to take Clomiphene?

To begin with, we must emphasize that this treatment should only be performed and supervised by a doctor, preferably a specialist in the female reproductive system (gynecologist) or at least an infertility specialist. Remember that this is an almost hormonal therapy, so it can have quite delicate adverse effects that we will explain later.

Furthermore, it is necessary for you to know that each person should have a totally personalized treatment, adapted to the basic needs and requirements, which will depend on the underlying pathology and the impact of this on our body. Not all people need the same dose or the same cycles.

In women the standard dose, at least the initial one, is 50mg once a day, for about five days (which should be especially between day 5 and 9 of the menstrual cycle). For women with PCOS alone, the initial dose may be slightly less (up to about 25mg once a day).

Other particular cases are women with recent menstrual bleeding or induced bleeding, in whom therapy should be started 5 days after the start of the cycle, one day after the bleeding stops. In the case of women who have not had recent bleeding, there is no major problem. If ovulation does not occur with this strict dosing regimen, it may be necessary to increase the doses a little more during the same 5 days of the cycle.

Ideally, doses should not exceed this 100mg cap, however, there are various protocols and scientific studies that claim that it is possible to reach 200mg per day, although side effects also skyrocket. If ovulation does not occur after 3 continuous cycles, the diagnosis should be reconsidered since the effectiveness of this drug is quite high.

Even if an attempt is made for six cycles (corresponding to approximately 6 months), clomiphene cannot be used again. It should be discarded as one of the options to overcome female infertility.

However, as we have mentioned, the only people who can use clomiphene are not women, also men. Idiopathic oligospermia is treatable with this drug. Although several different dosage regimens are used, the fact is that by using 25mg a day for about 25 days, positive results can be obtained.

It has also been tried with daily treatments with 25mg per day, and even higher doses reaching 50mg per day. Of course, all this requires detailed and very professional monitoring of sperm count and motility throughout the treatment. This will be applied until pregnancy occurs or 12 months are reached, where it is understood that the drug will not be effective.

Algorithm for the treatment of various forms of infertility

Contraindications: When can I not use Clomiphene?

As we have mentioned from the beginning, clomiphene is only effective for those women who have a totally intact H-H-O (hypothalamus-pituitary-ovarian) tract. If this is not the case, we will only have unwanted adverse effects. Therefore, the first notorious contraindication is that it cannot be used in patients with any alteration of that system.

Furthermore, some other cases such as patients who have insufficiencies (adrenal, pituitary, etc.) or some other alteration within the system, cannot be treated with this drug. There will simply be no response due to the mechanism of action of clomiphene. Other things that will lower estrogen levels if they can be treated with clomiphene.

It is not possible that foreign drugs are used to try to boost the effect of this drug. One of the most convenient and researched options is octreotide, however, outside of this there are not many options that have been shown to be useful in this case, even for men.

Of course, just like any other drug in the world clomiphene cannot be used in patients or people who have allergies or hypersensitivity reactions to it. Hypersensitivity to the drug or any of the components of the formula must be ruled out. It is even necessary to rule out neoplasms or functional alterations that may interact with the drug.

In the case of men, the only real indication is idiopathic oligospermia (of unknown cause despite multiple studies). Therefore, anything else that attempts to treat it must be totally contraindicated. It is neither functional nor healthy to attempt to treat any other disease with this drug.

Some available studies claim that clomiphene may act as a carcinogen, or at least as a major risk factor for the development of certain types of cancer. Some have even wanted to report (with high levels of speculation) that clomiphene, because it increases levels of estrogen (the prerequisite for ovulation to occur), may influence the development of ovarian and breast cancer, the most important risk factor for which is exposure to estrogen.

However, in several studies that were conducted, such as one long-term study on almost 1200 infertile women, the incidence of cancer was not significant in the group that underwent clomiphene therapy. Neither ovarian cancer nor breast cancer was significant. Although many more studies are needed, these results are important and support the use of this therapy.

Many studies need to be done on women who are about to use clomiphene, not only to confirm the cause but also to rule out other possible pathologies that are currently coexisting with the cause to be treated. For example, it is not possible to use this drug in women who have an ovarian cyst (unless it is due to polycystic ovary syndrome) or some serious alteration of the ovaries.

In order to minimize the risk, it is necessary to start with very low doses to try to induce ovulation. Thus, if there is an underlying contraindication that was not identified (such as a tumor), then there will be time to treat the patient and be cautious about its evolution.

Also, it is necessary to know that each person is different and reacts differently to the use of this drug. The expression on the estrogen receptors can vary depending on the genetics. Therefore, some women may be much more sensitive to the use of this drug. This is another compelling reason to start with low doses.

All patients should also be trained. In case of any symptoms regarding the enlargement of the ovaries, which can not only be pain but also nausea and vomiting, you should immediately stop. Remember that clomiphene is a rather delicate drug. Hyperstimulation of the ovary is a fairly likely syndrome, so it must be treated in time. The maximum enlargement should be noticed several days after the end of the treatment, so the follow-up should be exhaustive.

On the other hand, let us remember that this drug has a hepatic metabolism and is excreted by the bile, so it can only be used in people who have that system in total normality. Those who have suffered from any liver problem should be evaluated to see if it is possible or not to use clomiphene. Remember that if it is not metabolized, it will accumulate in our body in a harmful way, increasing excessively the amount of estrogen and causing many adverse effects.

There are many cases in which, although clomiphene can be used, it must be done with great caution. This is the case of patients with thrombophlebitis or active embolic diseases, major depression, psychosis, etc. There are many causes that may not be a direct contraindication, but they are cases in which it is better not to use this drug.

Side Effects

Like all drugs in the world today, clomiphene has adverse effects. However, according to the specialists behind the creation and supervision of this drug, they are well tolerated and allow for the continuation of treatment.

In many cases patients experience vasomotor "hot flashes" (more than 10%), which usually disappear after exposure to clomiphene without major complications. In addition, some alterations that may also occur are pelvic discomfort (without structural alterations), nausea, vomiting, breast pain, fatigue, and even headache.

In very few cases, pain associated with ovulation may occur, days after the use of clomiphene, so there are no major problems. It is normal for the mucosa of the uterus (and the rest of the anatomical structures of the reproductive system) to have certain alterations due to continued exposure to high amounts of estrogen, as this is the effect of the drug.

Even so, unfortunately, in some cases a counterproductive effect can occur, which is the increase in density of the cervical and uterine mucus, which does not allow the correct movement of the sperm to the egg. Even symptoms typical of menopause such as vaginal dryness can occur.

One out of seven women seems to experience alterations on the ovary, where an uncomplicated abnormal growth or enlargement could be observed. It may be necessary to perform certain tests throughout the process to ensure that no extra changes occur and that everything is within the normal limits of clomiphene use.

As we have mentioned, this drug can cause OHSS in women who are more prone to it because they have many more receptors than normal, even though estrogen levels are low. It is necessary to highlight that the plasma activity of certain important enzymes in our body can be altered in association with this syndrome, creating other adverse effects.

The most severe cases have shown effects such as abdominal pain and distension, nausea, weight gain, even ascites, difficulty breathing and other lung problems that can prevent our body from functioning normally. In addition, certain studies involve the abnormal accumulation of fluid in certain parts of our bodies, such as the lungs, heart, and abdomen.

Finally, it should be noted that some patients have shown vision problems associated with normal treatment in at least 1.5% of patients. Even so, this is very rare but can increase as the dose needed for each individual increases. It is also important to note that the accompanying symptoms in this case are double vision, blurred vision, spots and flashes (scintillating scotomas) and even photophobia (discomfort with light).

Very few cases have been described where there is a severe decrease in visual acuity, such as blindness. In addition, visual symptoms may be accentuated using other drugs that are not fully approved for infertility.

Other adverse reactions, such as dermatological and central nervous system reactions, have a frequency of less than 1%, so this is not really something we should be concerned about. In this group can appear erythema, hair loss, itching, psychosis, insomnia, restlessness, etc.

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Female Infertility: Why Can’t I Get Pregnant?

Fertility and infertility are quite delicate issues which have been displaced over time due to the diversity of alternatives to combat it. Both men and women are the cause of this problem, and we cannot blame only one.

In fact, the concept of infertility is an inclusive one. It is not based on the problem of a woman or a man, but on that of a couple. In short, it is the inability of a sexually active couple who are not on contraception to achieve a pregnancy after achieving it - properly - for one year.

Let's give back a little. First, how does a pregnancy occur? What does it take? We need to understand how everything works to get to the root of the problem.

In principle, it takes both an egg and a sperm. These are two specialized reproductive cells, which are essential to give rise to pregnancy. The ovary needs to function properly and release at least one egg per month from each of the fallopian tubes.

On the other hand, the man's sperm must be able to travel from the vagina to the fallopian tubes and fertilize the egg. The egg, in turn, once fertilized, must move into the uterus and implant. This is the normal path for reproductive cells.

Many people believe that this is a problem unique to men, but it is not. Statistically, only 40% of cases are related to female infertility. Understanding this is the first real step we must take to understand what is really going on in our bodies.

Causes of Female Infertility

The focus of this article is on the causes of female infertility. Not only because there are so many of them, but because knowing what the problem is is the only way to look for and find a solution that is really effective. Even in the most complex cases, it has been possible to obtain a product.

However, what happens in our bodies? Why can't we have children? Our first recommendation is that you go to a specialist who can give you a general overview of your problem depending on the alterations that exist, however, we also comment on the most frequent - and important - causes of female infertility:

Anovulation

More than 20% of cases are due to anovulation, the term given to the absence of the egg in a fertile woman. Many times it is accompanied by problems in the menstrual cycle (amenorrhea or oligomenorrhea), however, women who do not ovulate may suffer from several symptoms at the same time.

In turn, anovulation can have many causes and be associated with various factors, especially in the hormonal area. In fact, this is the main cause of early menopause.

Sometimes it is associated with "superior" problems, located in the hypothalamus or pituitary gland, or disorders in the balance that must exist between the pituitary gland and the ovaries, or some disorder of the ovaries themselves. Whatever the problem is, it is one of the most frequent and important causes that must be (and can be) treated.

Hyperprolactinemia

One of the central hormones of the pituitary gland is prolactin, which plays a crucial role once the baby is born and you must breastfeed, as this is the true producer of milk. However, there are some cases where it starts to secrete abnormally, which generates direct complications and, of course, infertility.

The first symptom, and perhaps the only important one, is that women (without even being pregnant) start secreting milk without control. Although sometimes it seems insignificant (because it can be very small amounts, as it is enough to inhibit several processes related to pregnancy).

The most frequent causes are thyroid problems, benign tumors, some drugs, stress and even oral contraceptives. Depending on the underlying cause, there will be specific treatments and therapies.

Polycystic Ovary Syndrome

This is perhaps one of the most frequent disorders in women (in general), and one of the most underdiagnosed. We talk about polycystic ovary syndrome when the eggs, which are supposed to be producing hormones and being released into the tubes, as they get trapped in the ovary.

Because the eggs grow but are never released, then there appear to be many cysts (small, fluid-filled, circular formations) within the ovaries. It needs to be treated so that you can get pregnant, however, it is possible.

Some symptoms that may accompany PCOS are irregular menstruation (even stopping), weight gain, excessive hair, acne, oily skin, etc. These are all direct changes in PCOS and in most cases are related to insulin disorders.

Yes, the same hormone that is missing in diabetes can trigger this disease, but in this case the opposite is true. In other words, there is too much insulin circulating and it is altering each of our systems, especially the reproductive system.

Insufficiency

Imagine for a second that you have everything perfect (not just your ovaries but the rest of your reproductive system). The eggs grow and are released normally, but... there are not enough of them. This is ovarian failure.

From the moment you are born, the number of eggs that are with you does not vary. It's not like other cells that just keep regenerating, dying and being born again. In the case of the ovaries this does not happen, you have an ovarian load from birth and you only lose it as the years go by.

Some women have fewer eggs than others, so that reserve is depleted much faster and is what is showing early symptoms (menopausal symptoms, of course).

Beyond the Ovary

You thought the only thing that could be wrong was the ovary? It's not. There's a lot more to it than that. As we explained before, the spermatozoon has a long path and, any of the things in that path can be altered and prevent fertilization from being achieved.

We go from the top down. Once the egg is expelled from the ovary, where does it go? Well, the only place it can: the fallopian tubes. These are two tubes that go from the ovaries to the uterus and oversee being the site of fertilization (since in 95% of the cases there is a union between the sperm and the egg).

Many diseases, especially sexually transmitted diseases, can alter the shape and structure of the fallopian tubes. This would not only complicate the ascent of the sperm from the uterus, but also make it difficult for the egg to descend normally. In addition, something important occurs: there are changes in the small environment of the tubes.

What does this mean? That there are changes in the pH or movement of the cilia and mucous membrane in that region. This means that the sperm can die on the way because the conditions are not suitable for it to travel. However, this is not the only thing. What is beyond the tubes? Well, the uterus. It is also frequent that there are classic alterations in this organ that not only involve changes like those of the fallopian tubes, also caused by sexually transmitted diseases (more frequently), but also alterations in other aspects.

For example, the cervical mucus is crucial for that first adhesion to exist and for not losing the pregnancy later. If there is no good cervical mucus, there will be no pregnancy or a very high risk of losing it.

But is that all? Is there nothing else that can happen? Unfortunately, this is a really long list that doesn't end here. Other kinds of problems such as stress, serious diseases (hypertension, diabetes, etc.), problems with sexuality, age, weight. There are too many causes to mention, so the study of people with infertility can be quite thorough.

Diagnosis of Female Infertility

The first thing, as we told you before, is that you go to a specialist so that your diagnosis can be a little more directed. Believe us, it is quite long and complex and the solution can be hidden among thousands of different data, so it is better to have a specialist who knows your case personally and can guide you better.

In order to reach an unambiguous conclusion as to what your problem is, the first thing to do is to have a hormone test. Not only is estrogen (which is the best known) evaluated but also other key hormones in the functioning of your body: LH, FSH, HCG, TSH, etc. It's a pretty comprehensive study but it provides a lot of information.

Of course, all this is necessary because the purpose is for you to be able to have children, however, the cause of infertility may be hidden and overlapping under multiple processes that may be attacking you at the same time. In addition, it is worth noting that many times the changes are irreversible, so the only alternative is to look for new options to try to get pregnant.

If the fallopian tubes have been affected due to a previous disease, such as a sexually transmitted disease, your specialist can search for the eggs that are born from your ovaries and find a viable alternative to achieve pregnancy. Although it can be complex, it is still possible.

Treatment for Infertility

As we have been talking about, the treatment can be really complex and will depend directly on the cause. We can not give a general answer since each case will have its optimal solution, however, if we can tell you something: in most cases it is possible to get pregnant.

Even so, to achieve it it is necessary to go through rigorous diagnostic stages and some therapeutic methods, always putting first, of course, the various techniques that exist to improve the sexual act. Remember, part of the key is that the sperm can travel well, so a push is never too much.

Let's go from less to more for a second. Your doctor should analyze the underlying cause, your age, the anatomical state of your reproductive organs and then come to a consensus. What are the alternatives you have? Here are the most important ones:

Hormone therapy

Clomiphene, for example, is one of the most interesting options for encouraging ovulation (in women who cannot ovulate), including FSH and LH injections. It can even work for women who can't find a clear cause. However, they often combine it with intrauterine insemination and other special processes to increase the chance of pregnancy by a high percentage.

Remember, this depends on the patient. If there is an anatomical alteration (such as a problem in the uterus and tubes) we will not do anything with a hormonal solution, it is necessary to attack the center of the problem.

Surgery

This may be the ideal alternative for women like the ones we are proposing. If you have problems in the uterus (fibroids, uterine polyps, scar tissue, etc) or in the tubes, this may be an ideal option. Also, even in women who have tubal blockage it can help. Still, there are also things that are not as good with surgery as ectopic pregnancy.

Altering a woman's normal anatomy can cause the fetus to implant in an abnormal site (ectopic pregnancy), resulting in an unviable product. Therefore, the surgery must be properly prepared, and the future must be planned.

Assisted Reproduction

This is perhaps one of the most complex, but also most effective, measures. It involves mixing the sperm with an egg outside the body and attempting to transfer the resulting embryo into the uterus. Some women use a donor egg in case they cannot use their own.

Without a doubt, female infertility is a radically important problem, like what happens with male infertility. Although there is no definitive solution, there are certainly certain options to improve and increase the likelihood of pregnancy, so don't give up, there is an option around the corner waiting for you.

By: Dr. Anat Zelmanovich