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Use of a new SUB CUTANEOUS progesterone preparation in IVF cycles

It is well documented in the IVF literature that it is necessary to administer progesterone (P) after egg retrieval. The two commonly used routes for administering P are with intra-muscular (IM) injections or vaginal (Crinone 8%, Endometrin). IM injections of P are painful, can cause local inflammation and sterile abscesses (collection of pus). Patients prefer vaginal preparations to the dreaded IM injections. However, for some women, the vaginal route is unacceptable. The vaginal preparations can be associated with a discharge and local irritation.

Until now, injectable P was offered only in an oil-base solution owing to the insoluble properties of the molecule, which made the IM route mandatory. A recent publication demonstrated the efficacy of a new P formulation (Prolutex) that could be a game changer. Scientists at the Institut Biochimique in Lugano, Switzerland have combined P with cyclodextrin (a starch residue) making it water-soluble (aqueous)! It can therefore be given subcutaneously (SC) i.e. under the skin, with a tiny needle!

Does this new formulation work?

A brand new study in the journal Fertility and Sterility suggests that it does! (Lockwood et al., 2013). They evaluated Prolutex at 13 European fertility clinics. A total of 683 patients were randomized to two groups: Prolutex 25 mg sc daily (n = 339) and Crinone, 90 mg 8% gel daily (n = 344). On the day of egg retrieval, Prolutex or Crinone gel was begum for luteal phase support and continued for up to 10 weeks. The ongoing pregnancy rates at 10 weeks of treatment were 27.5% and 30.5% in the Prolutex and Crinone group, respectively. The delivery rates (26.8% vs. 29.9%) were also similar in the two groups. The adverse event profiles were similar and Prolutex was safe and well tolerated.

The authors further state that contemporary IVF relies otherwise almost entirely on SC injections for agonist, antagonist, and gonadotropin therapy, and women feel confident and comfortable in self-administering these injections. Some women, for reasons of cultural and religious sensitivity, particularly once a pregnancy has been confirmed, are uneasy and reluctant to use medications that require vaginal insertion and are concerned about the leakage associated with gels and pessaries, fearing that they have not absorbed an adequate dose, and insertion of a vaginal preparation in case of spotting or vaginal bleeding can be unpleasant. In addition, the vaginal manipulation when performed in suboptimal conditions (a not properly clean environment) may increase the risk of genital tract infections, which have been shown to be one of the causes of spontaneous abortion, preterm births, and poor pregnancy outcome if not treated in a timely manner. This new product may therefore be a good alternative for these patients.

The new product will have to get approved by the FDA before it is available here in the U.S. I hope the approval for Prolutex is quick as will increase the options available for patients. It will be a boon especially for women disliking vaginal treatments for cultural or personal reasons.

Infertility treatment IVF Early pregnancy

Dr. Vishvanath Karande

Dr. Vishvanath Karande

Dr. Karande is Board Certified in the specialty of Obstetrics and Gynecology as well as the subspecialty of Reproductive Endocrinology and Infertility. He is a Fellow of the American College of Obstetricians and Gynecologists and Member of the American Society for Reproductive Medicine.

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