Administering
Medications
Instructions For Ovulation Induction Or Controlled
Ovarian Hyperstimulation With Gonadotropins
Introduction:
Induction of ovulation with gonadotropins requires
advanced training of the physician and a great deal of
patient and physician commitment. All of RMA's
physicians are highly qualified to provide this
treatment. Our offices are open 7-days a week to provide
the access necessary for optimal treatment. These
therapies are not without risk and should be used only
as directed and with close monitoring and follow-up.
The Drugs:
Each of these drugs is a protein hormone. Gonal F and
Follistim Pen are made by recombinant DNA technology,
while Menopur, Fertinex, Bravelle, Repronex, Humegon and
Pergonal are isolated from the urine of menopausal women
and freeze-dried into a powder. All of them have been
specially processed to ensure maximum safety and
potency. Because they are in powder form, they must be
reconstituted with sterile water or saline before
injection. The hormones that these drugs provide are
Follicle Stimulating Hormone (FSH) and Luteinizing
Hormone (LH), which are hormones that your pituitary
gland normally produces. Although FSH is the hormone
primarily responsible for follicular development, both
FSH and LH play a role in the normal development and
ovulation of ovarian follicles. LH is normally
responsible for triggering ovulation when a mature
follicle is present. Each of these drugs acts directly
on the ovaries and do not have activities elsewhere in
the body.
Gonal F / Follistim Pen:
(75 IU FSH, no LH) are pure FSH made by recombinant DNA
technology and are given subcutaneously. Gonal F is made
by Serono Inc and comes in ampules (75 IU) and
multi-dose (1200 IU) vials. Follistim is made by
Organon, Inc and comes in vials (75 IU)
Menpur:
(75
IU FSH, < 0.1 IU LH):
is
almost pure FSH and is given subcutaneously. Menopur is
a more purified form of Bravelle and is made by Ferring,
Inc.
Bravelle:
(75IU FSH, 1.0 IU LH) highly purified FSH and is given
subcutaneously. Is similar (but more highly purified to
the old drug Metrodin. Bravelle is made by Ferring, Inc.
Repronex / Pergonal / Humegon:
(75IU FSH, 75 IU LH): is an equal mixture of both FSH
and LH. Repronex is made by Ferring, Inc and can be
given subcutaneously. Pergonal is made by Serono, Inc;
Humegon is made by Organon, Inc. Both Pergonal and
Humegon are given intramuscularly.
hCG:
human chorionic gonadotropin, the "pregnancy hormone".
Its actions are identical to LH, but it lasts longer. It
is used to simulate the normal midcycle LH surge, which
causes the final maturation of the egg and ovulation. It
is used because the FSH-containing drugs have altered
the normal feedback mechanisms and the LH surge may not
occur on its own.
Profasi, Pregnyl
and
Novarel
are
isolated from the urine of pregnant women and given
intramuscularly.
Profasi
is
made by Serono, Inc,
Pregnyl
is
made by Organon, Inc and
Novarel
is
made by Ferring.
Ovridel
is
hCG that is made by recombinant DNA technology by Serono
and is given subcutaneously.
Indications for Treatment:
In
women who do not ovulate on their own, these drugs
induce ovulation, thus the term Ovulation Induction. In
women who do ovulate on their own, these drugs are used
to produce more follicles from the ovaries in a
controlled fashion, thus the expression Controlled
Ovarian Hyperstimulation (COH). Gonadotropins are a
first line drug for anovulatory women with normal to low
FSH and LH levels. They are a second line drug for women
who fail to ovulate or conceive after optimal clomiphene
citrate (and/or metformin) therapy. They may also be a
first or second line drug for ovulatory women with
unexplained infertility and endometriosis. In most
women, any of the six FSH-containing gonadotropins may
be appropriate to use. However, in certain situations,
one drug may be more advantageous to you. The choice of
medicines will be discussed at your counseling session
prior to initiating therapy.
Monitoring
1.
It
is essential that close monitoring with ultrasound and
blood tests (estrogen and progesterone) be done to
reduce the chances of adverse consequences and to
increase the chances of success.
2.
Please call the office when your period starts (day 1 of
your cycle).
If your period starts after 9:00 pm, day 1 is the next
day. Medicines are usually started on day 3 of the
cycle. A baseline ultrasound and blood-work are required
before starting the medicine. You should call to arrange
testing as soon as your period starts. If your period
starts on a weekend, please leave a message at
248-619-3100. We can start the medicine between days 3-5
of the cycle; your doctor will determine the start after
review of the baseline studies.
3.
The
tests that will be done initially and at most visits
will be an ultrasound and two blood tests: estrogen and
progesterone. The ultrasound determines how many
follicles are developing and how mature they are, based
on their size. The estrogen level is a reflection of the
follicle's activity. The progesterone level also
reflects follicular activity and is a tip-off of
ovulation starting to occur spontaneously
4.
After the baseline tests, you will take the medicine 3-5
days, then return for an ultrasound and blood tests.
Lab results are reported late in the afternoon after the
physicians have reviewed them. You will be called at
your home number by a nurse or physician and informed of
(a) adjustments in medicine dosage, or (b) when to
return for repeat testing. Most cycles will have 3-6
rounds of tests.
Thus, you should expect to be seen every 1-3 days until
the follicles are mature.
5.
If you have not been called with your results and plans
by 7:30 pm, please call our emergency number at
248-619-3100. Our answering service will contact a nurse
or a physician for you.
6.
Once we have reached our goals for follicle development
and the estrogen is in a safe level hCG will be give to
induce the final maturation of the egg and ovulation. Do
not take the hCG until you are told to. hCG is given
because spontaneous ovulation will occur in only a small
number of women treated with these medicines.
7.
We
generally do two inseminations (IUI's) because we feel
that it increases the chances of conception. The
inseminations will be about 12 and 36 h after the hCG
injection. If inseminations are not used, timing of
intercourse will be discussed with you.
8.
About 5 days after the hCG, a progesterone level will be
drawn to confirm that ovulation did occur.
9.
The
earliest a pregnancy test may be done is 16 days after
the hCG was given. Please call if you get your period
sooner.
Adverse
Reactions and Risks to Gonadotropin Therapy
Local irritation at injection site.
Symptoms of estrogen excess (dizziness, nausea,
headaches, mood swings irritability, hot flashes, breast
fullness or tenderness)
Ovarian enlargement
Ovarian\ Torsion (twisting of an ovary, usually because
it is enlarged)
Ovarian Hyperstimulation Syndrome
Multiple pregnancy
Miscarriage
Ectopic (tubal) pregnancy
Cycle cancellation
Multiple Pregnancies:
Multiple pregnancies are more common with gonadotropins
than with clomiphene citrate (Clomid, Serophene). The
risk is directly proportional to the number of mature
follicles. Overall, multiple pregnancies represent 15-20
% of the gonadotropin induced pregnancies with 2-5 % of
all pregnancies being high order multiple pregnancies
(e.g. Triplets or more)
Ovarian Hyperstimulation Syndrome (OHSS)
is
a sudden enlargement of the ovaries and accumulation of
fluid in the abdomen. It can be a rapidly progressive
medical emergency, which may require hospitalization and
even intensive care services in its worst form. The
cause is unknown, but it is associated with high
estrogen levels. Many of the women who develop it are
pregnant. The monitoring is designed to attempt prevent
OHSS from occurring. Still, it happens in milder forms
in 5-10% of gonadotropin cycles. Severe forms are less
common. Early symptoms may include weight gain ( over 5
pounds), bloating, nausea vomiting, diarrhea and
shortness of breath. If you think you have these
symptoms, please notify us immediately.
Cancellation of the Cycle:
Canceling the cycle (not giving the hCG or doing the IUI)
can prevent OHSS and multiple pregnancies. At times,
this may be the safest way to proceed. Cycles may also
be canceled for inadequate response.
Results of Ovulation Induction / Controlled Ovarian
Hyperstimulation with Gonadotropins
This is listed to provide you with an overall
perspective regarding the general effectiveness of this
therapy. The results that you obtain are dependant upon
many factors including the woman's age, quality of sperm
and quality of pelvic anatomy, as well as other
diagnoses that may be present.
|
Indication for Ovulation Induction or COH |
% Ovulating (per cycle) |
% Pregnant (per cycle) |
Total % Pregnant after 3 cycles |
|
Anovulation (e.g. PCOS) |
75 - 90% |
14 - 17% |
37 - 42% |
|
|
|
Unexplained infertility / Endometriosis (no IUI) |
100% |
8.7% |
23.8% |
|
|
|
Unexplained Infertility / Endometriosis (with
IUI) |
100% |
17 - 25% |
42 - 56% |
Additional
Risks:
Congenital anomalies: risk equal to the general
population.
Miscarriage Rate: 20-25 %, about equal to the general
population. Is age dependent
Ectopic Pregnancy Rate: 2-5%, equal to or slightly
higher than the general population
Duration of Therapy:
3-6
cycles.
Telephone Numbers:
Troy Office: 248-619-3100
Toledo Office: 248-619-3100
Our Main Office: (248)-619-3100
