“Luteal phase” is the name for the time period following ovulation; in natural cycles, it is when a fertilized egg implants in the uterine lining (endometrium) to grow and develop. In IVF cycles, it is the time following ovulation and egg retrieval when the fertilized egg, or embryo, is transferred back into your uterus, also to implant.

Progesterone is a hormone that is considered key in making the endometrium receptive to implantation. During IVF, when your natural hormones are suppressed, your doctor will prescribe supplemental progesterone. It may also be given during natural cycles when the doctor suspects a “luteal phase defect” has been causing miscarriage.

Supplementing progesterone during IVF

Progesterone supplementation is usually begun on the evening of or the day following egg retrieval, to begin to prepare the uterine lining prior to embryo transfer.

Supplemental progesterone is initially prescribed until the first or second pregnancy test. Then, if you are pregnant, the prescription is refilled for about another 8 to 10 weeks, although this can vary from doctor to doctor. At the end of that time, the placenta will be more fully developed and produce its own supply of hormones to support the rest of the pregnancy.

Sometimes there is mild bleeding or spotting when using progesterone, so do not assume that you have miscarried. Continue taking your progesterone medication and consult with the doctor.

Questions & Answers

Q. I’ve heard there are different ways of taking progesterone. What are they?
A. There are a number of options available, and your doctor will decide which one best fits your individual needs. Here are the current methods from which your doctor may choose:

Injectable Progesterone – Suspended in oil and administered daily, or sometimes twice daily, progesterone is administered using a needle injected into a muscle (intramuscularly, or IM). PROS: Because doctors can measure your blood levels during treatment, they feel more secure prescribing it. CONS: Unfortunately, the needle gauge (thickness) has to be relatively large to accommodate the oil; this can cause great discomfort. It is also difficult to inject yourself, as the area of injection is small and hard to reach; a partner, nurse or friend must be available to help. What’s more, some women are allergic to the kind of oil (such as peanut oil) that is used to deliver the progesterone.

Oral Progesterone – This is progesterone available in capsule form. PROS: This form is easy to take.
CONS: Some women may experience sleepiness, dizziness, or lightheadedness. As the capsule uses a base of peanut oil, you cannot take it if you have a peanut allergy. Also, since doctors have a concern about how much progesterone gets through the digestive tract, it is not that popular a method.

Vaginal Progesterone – This form of progesterone is designed to deliver medication directly to the site by various methods:

Progesterone Inserts – ENDOMETRIN^® (progesterone) Vaginal Insert 100 mg, is the first and only progesterone vaginal insert approved by the FDA for use in luteal support that is administered vaginally 2 or 3 times a day.¹
PROS: ENDOMETRIN^®…

• Achieved excellent pregnancy and birth rates in the largest IVF clinical trial ever conducted in the United States²
• Achieved excellent pregnancy and birth rates in clinical studies versus progesterone-in-oil injections^3-5
• Is specially designed to dissolve as it delivers progesterone⁶
• Is easily administered using a specially designed, disposable applicator¹
• Was preferred by the majority of patients surveyed over all other vaginal progesterones*⁷

Progesterone Suppositories – These are compounded by individual pharmacies on your doctor’s specifications, and inserted vaginally one or more times a day. They are compounded in fatty acid or polyethylene glycol (PEG), and melt on contact with your body to release the progesterone. PROS: It’s not a shot. Also, doctors sometimes prescribe progesterone suppositories to supplement a daily IM injection.
CONS: They can be messy. Also, some women may have a reaction to the compounding material. What’s more, the amount of medication you receive can vary from dose to dose.

Vaginal Progesterone Gel – This is progesterone in a gel base which you insert daily.
PROS: It is easy to dose using a single-use applicator.
CONS: Because the gel is made to adhere to the vaginal walls, buildup and blockage can be a problem; you or your doctor may need to clear it manually. Also, some women can have a reaction to or irritation from the gel itself.

At Ferring, we’re always looking for ways to make medications more comfortable and convenient and provide you with information that, along with your doctor’s advice, helps you explore treatment options that may be right for you. Keep checking this site for more new product news as it becomes available.

ENDOMETRIN^® administered as a progesterone vaginal insert is indicated to support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment for infertile women.

Important Safety Information

Only physicians thoroughly familiar with infertility treatment should prescribe ENDOMETRIN^®. In clinical trials (n=808), adverse reactions that occurred at a rate greater than or equal to 2% included: uterine spasm (3% to 4%) and vaginal bleeding (3%). Vaginal irritation, itching, burning or discomfort, urticaria, and peripheral edema were reported at an incidence of less than 2%. ENDOMETRIN^® is expected to have adverse reactions similar to other drugs containing progesterone (breast tenderness, bloating, mood swings, irritability, and drowsiness). ENDOMETRIN^® is contraindicated in women who have or have had previous allergic reactions to progesterone or any of the ingredients in ENDOMETRIN^®; a known missed abortion or ectopic pregnancy; liver disease; known or suspected breast cancer; active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events.

Click here to see Patient Prescribing Information for ENDOMETRIN^®.

Click here to see Full Prescribing Information for ENDOMETRIN^®.

REFERENCES: 1. ENDOMETRIN^® [prescribing information]. Parsippany, NJ: Ferring Pharmaceuticals Inc; June 2007. 2. Doody KJ, Schnell VL, Foulk RA, et al. Endometrin for luteal phase support in a randomized, controlled, open-label, prospective in-vitro fertilization trial using a combination of Menopur and Bravelle for controlled ovarian hyperstimulation. Fertil Steril. 2009;91:1012-1017. 3. Khan N, Richter KS, Newsome TL, et al. Matched-samples comparison of intramuscular versus vaginal progesterone for luteal phase support after in vitro fertilization and embryo transfer. Fertil Steril. 2009;91:2445-2450. 4. Mitwally MF, Diamond MP, Abuzeid M. Vaginal micronized progesterone versus intramuscular progesterone for luteal support in women undergoing in vitro fertilization-embryo transfer. Fertil Steril. 2009 April 9. [epub ahead of print] 5. Beltsos AN, Elgar C, Robertson A, et al. Luteal phase support with Endometrin vs progesterone in oil in in vitro fertilization cycles. Presented at: 64th Annual Meeting of the American Society for Reproductive Medicine; November 8-12, 2008; San Francisco, CA. 6. Data on file. Ferring Pharmaceuticals Inc. 7. Progesterone Supplementation: Evaluation of Attitudes and Satisfaction with Endometrin (EASE). Results of an Online Patient Survey. Parsippany, NJ: Ferring Pharmaceuticals Inc.; 2008.

*In a nationwide survey of fertility patients undergoing ART conducted from May 2008 through August 2008 who had used ENDOMETRIN and other progesterone options. ENDOMETRIN^® was preferred by: 84% of patients (n=62) who had used both ENDOMETRIN^® and Prometrium^® capsules administered vaginally; 88% of patients (n=83) who used both ENDOMETRIN^® and progesterone suppositories; 69% of patients (n=26) who used both ENDOMETRIN^® and Crinone^®/Prochieve^® gel.

Crinone^® and Prochieve^® are registered trademarks of Columbia Laboratories, Inc.

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