Why Progesterone May Be Recommended for You:
Progesterone therapy is recommended for women who have infertility
(or habitual miscarriages) secondary to a problem called luteal
phase deficiency. Luteal phase deficiency is a result of inadequate
production of progesterone by the ovaries during the second half
of the menstrual cycle. The ovaries continue to make progesterone
during the first 8 weeks of pregnancy (since the last menstrual
period). If there is insufficient progesterone during early pregnancy,
the embryo may not survive. After the 8th week the placenta becomes
a major source of progesterone and the ovarian hormones are no
longer needed. Women can develop luteal phase deficiency after
receiving the ovulation medications for In Vitro Fertilization
(IVF). Progesterone is prescribed after OI and IVF to insure against
luteal phase deficiency.
The need for progesterone supplementation in early pregnancy in women with luteal phase deficiency has not been clearly established. However, it is assumed that if the ovaries cannot make sufficient progesterone during the latter half of the menstrual cycle, then they would not produce the required amounts of progesterone during pregnancy as well. In women with luteal phase deficiency, it has been customary to extend the progesterone treatment into the early weeks of pregnancy to supplement ovarian production of progesterone.
We currently recommend progesterone therapy in early pregnancy for women who have deficient progesterone production during the latter part of their menstrual cycle, or who have been given medications to induce ovulation for In Vitro Fertilization. The natural progesterone compounds used for this therapy are either identical or very similar to the natural hormone. You may be concerned about the safety of using progesterone in early pregnancy. There is no accurate figure, but well over a million children worldwide have been subjected to such therapy during their mother's pregnancies. There has never been any pattern of birth defects reported in patients so treated. However, there can be no guarantees that there will be no birth defects since 2% of all births are associated with some sort of birth defect (usually mild). But, we can say there is no reported increase in the rate of birth defects with progesterone therapy prescribed in early pregnancy. Please feel free to discuss this situation in more detail with your doctor.
Package Labeling:
In the 1970's, a series of reports appeared that linked synthetic progestins with birth defects. Shortly thereafter, the Food and Drug Administration required that a warning be placed in the package insert of all progestin and progesterone- containing compounds, stating that these compounds should not be used during early pregnancy. Most of the data that linked progestins with birth defects have been withdrawn. In fact, the major study that made the connection between progestins and birth defects was found to have misinterpreted their data.
Natural progesterone has never been associated with birth defects in these studies or any others. This makes sense since progesterone is the dominant hormone produced naturally by the body during pregnancy. Nevertheless, the package insert still contains the warning and it is uncertain how long the FDA will continue to require this labeling. Naturally, one would become concerned after seeing this warning and therefore we are providing this explanation.
How Progesterone Is Given:
Most commonly, progesterone is administered by vaginal capsules
in ovulation induction and and in-vitro fertilization cycles.
Intramuscular injections are used primarily for donor egg cycles
and with the use of cryopreserved embryos.
Intramuscular Progesterone Administration:
Following an IVF procedure you will begin to take Progesterone I.M. daily until you have your pregnancy test. Progesterone is a hormone produced naturally in the body to insure a thick lining of the uterus, facilitating implantation of the embryo. Please call your coordinator for your exact dose.
The drug should be given via deep intramuscular (I.M.) injection with the syringes provided to promote absorption. If you should experience any rash or local reaction to the injection, please notify the office during regular hours.
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