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For ovulation induction/IUI cycles—

 

Add Crinone 8% to Support Endometrial Development, Implantation, and Pregnancy

 

Clomiphene citrate (CC) can have an antiestrogenic effect on the endometrium and cervical mucus

  • CC successfully induces ovulation in 50% to 75% of patients1,2 — but pregnancy rates are only 6% per cycle3
  • Dysynchronous endometrial transformation may result in deficient progestational effects in the late luteal phase1, including possible failed implantation2

 

 

Crinone 8% and estradiol correct the effects of CC

  • Higher incidence of normal endometrial development with CC + estradiol + Crinone 8%1

Study design: Results of a prospective, randomized trial of 37 women (aged 21–38 years) with oligo-amenorrhea who received ovulation induction with CC and IUI. Patients were randomized into 4 groups receiving either 50 mg (groups 1 and 2) or 100 mg (groups 3 and 4) of CC from cycle day 3–8. Groups 2 and 4 also received vaginal E2 cream 0.1 mg BID from day 8 until the LH surge and Crinone 8%, starting 3 days after ovulation. All participants had an endometrial biopsy performed 10 ± 1 days after ovulation.

 

*In-phase: ± 2 days of actual dating.

†Versus 50 mg CC + placebo (n=6).

‡Versus 100 mg CC + placebo (n=6).

 

Adding Crinone 8% and estradiol to CC may increase pregnancy rates

  • More than double the patients receiving Crinone 8% + estradiol + CC became pregnant versus patients receiving CC alone (17% versus 7%, respectively)7
  • Results are clinically different but are not statistically significant due to the small size of the study
Study design: Results of a randomized, open-label study of 71 oligo-ovulatory women. Patients were randomized into 1 of 2 groups—those who received only CC and those who received CC + hormonal supplementation (HS). All patients received 100 mg of CC from cycle days 3–7. Patients receiving HS started oral E2 at a dose of 1.5 mg BID on cycle day 8 and discontinued E2 at LH surge. Intercourse was encouraged starting on cycle day 10. Patients received Crinone 8% 3 days after LH surge and continued for 2 weeks or for a total of 12 weeks in case of pregnancy.

 

Click on the chart below for a larger view.

 

Schedule of therapy

  1. Clomiphene citrate 50 mg or 100 mg on days 3 to 7
  2. Estradiol 3 mg orally twice per day from day 8 to the morning of day 12
  3. Crinone 8% daily starting on day 17. If pregnancy occurs, continue for an additional 10 weeks

References: 1. Elkind-Hirsch KE, Phillips K, Bello SM, McNichol M, de Ziegler D. Sequential hormonal supplementation with vaginal estradiol and progesterone gel corrects the effect of clomiphene on the endometrium in oligo-ovulatory women. Hum Reprod. 2002;17:295–298. 2. Gerli S, Gholami H, Manna A, Di Frega AS, Vitiello C, Unfer V. Use of ethinyl estradiol to reverse the antiestrogenic effects of clomiphene citrate in patients undergoing intrauterine insemination: a comparative, randomized study. Fertil Steril. 2000;73:85–89. 3. Bayer SR, Alper MM, Penzias AS. The Boston IVF Handbook of Infertility: a practical guide for practitioners who care for infertile couples. Boca Raton, FL: Parthenon; 2002. 4. Sereepapong W, Suwajanakorn S, Triratanachat S, et al. Effects of clomiphene citrate on the endometrium of regularly cycling women. Fertil Steril. 2000;73:287–291. 5. Dickey RP, Holtkamp DE. Development, pharmacology and clinical experience with clomiphene citrate. Hum Reprod. 1996;2:483–506. 6. Adashi EY, Rock JA, Rosenwaks Z, eds. Reproductive Endocrinology, Surgery, and Technology. Philadelphia, PA: Lippincott-Raven; 1996:1199–1201. 7. Elkind-Hirsch KE, Darensbourg C, Creasy G, Gipe D. Conception rates in clomiphene citrate cycles with and without hormone supplementation: a pilot study. Curr Med Res Opin. 2005;21:1035–1040.