Archives of Gynecology and Obstetrics

, Volume 286, Issue 4, pp 1049–1054 | Cite as

A randomized comparison of the efficacy, side effects and patient convenience between vaginal and rectal administration of Cyclogest® when used for luteal phase support in ICSI treatment

  • Malek-Mansour Aghsa
  • Haleh Rahmanpour
  • Maryam Bagheri
  • Fatemeh Davari-Tanha
  • Reza Nasr
Reproductive Medicine

Abstract

Purpose

This study compares the efficacy, side effects and patient convenience of vaginal and rectal routes of administration of progesterone suppositories (Cyclogest) when used for luteal phase support during in vitro fertilization cycles, through the use of antagonist protocols.

Methods

147 patients who underwent intra-cytoplasmic sperm injection cycle were randomized on the day of the embryo transfer (ET) by a computer-generated randomization program to receive 400 mg of Cyclogest either vaginally or rectally twice daily for up to 8 weeks. A pregnancy test was conducted 2 weeks after embryo transfer. If the pregnancy test was negative, the application was discontinued. On day 14th after embryo transfer, patient’s acceptability and side effects were assessed using a questionnaire which was given to the patients on the day of ET prior to performing the pregnancy test. The clinical pregnancy rate at the 8th week of gestation and the level of luteal progesterone were evaluated.

Results

There were no substantial differences in the demographics or other characteristics between the two groups. There were no significant differences in serum P concentration 6 days after ET, the clinical pregnancy and abortion rates. The difficulty of administration route, the discomforts experienced following administration, and the proportion leaking out on the 14th day were similar between the two groups. Significantly more patients administering the medication per vagina had perineal irritation (21.3 vs. 2.2 %). The prevalence of tenesmus (35.1 vs. 21.1 %) and rectal itching (26.7 vs. 2.8 %) were significantly more in rectal route.

Conclusions

This study demonstrates that the efficacy of Cyclogest is similar when administered via both the vaginal and rectal routes. Although their side effects differ, the ease of administration for patients and their preference are similar.

Keywords

Luteal phase support Patient convenience Vaginal progesterone Cyclogest IVF 

References

  1. 1.
    Hubayter ZR, Muasher SJ (2008) Luteal supplementation in vitro fertilization: more questions than answers. Fertil Steril 89:749–758PubMedCrossRefGoogle Scholar
  2. 2.
    Dal Prato L, Borini A (2005) Use of antagonists in ovarian stimulation protocols. Reprod Biomed Online 10:330–338PubMedCrossRefGoogle Scholar
  3. 3.
    Fatemi HM, Popovic-Todorovic B, Papanikolaou E, Donoso P, Devroey P (2007) Update of luteal phase support in stimulated ICSI cycles. Hum Reprod Update 13:581–590PubMedCrossRefGoogle Scholar
  4. 4.
    Fatemi HM (2009) The luteal phase after 3 decades of IVF: what do we know? Reprod Biomed Online 19:4331PubMedCrossRefGoogle Scholar
  5. 5.
    Humaidan P, Papanikolaou EG, Kyrou D, Alsbjerg B, Polyzos NP, Devroey P, Fatemi HM (2012) The luteal phase after GnRH-agonist triggering of ovulation: present and future perspectives. Reprod Biomed Online 24:134–141PubMedCrossRefGoogle Scholar
  6. 6.
    Albano C, Grimbizis G, Smitz J, Riethmüller-Winzen H, Reissmann T, Van Steirteghem A, Devroey P (1998) The luteal phase of nonsupplemented cycles after ovarian superovulation with human menopausal gonadotropin and the gonadotropin-releasing hormone antagonist Cetrorelix. Fertil Steril 70:357–359PubMedCrossRefGoogle Scholar
  7. 7.
    Kolibianakis EM, Devroey P (2002) The luteal phase after ovarian stimulation. Reprod Biomed Online 5 Suppl 1 (3):26–35Google Scholar
  8. 8.
    Fauser BC, Devroey P (2003) Reproductive biology and ICSI: ovarian stimulation and luteal phase consequences. Trends Endocrinol Metab 14:236–242PubMedCrossRefGoogle Scholar
  9. 9.
    Bahceci M, Ulug U (2008) Route of progesterone administration for luteal phase support may affect outcome of controlled ovarian hyper-stimulation for ICSI with ICSI using GnRH antagonist. J Assist Reprod Genet 25:499–502PubMedCrossRefGoogle Scholar
  10. 10.
    ASRM Practice Committee (2008) Progesterone supplementation during the luteal phase and in early pregnancy in the treatment of infertility: an educational bulletin. ASRM Practice Committee Position Statement. Fertil Steril 90:S150–S153Google Scholar
  11. 11.
    Ng EHY, Chan CC, Tang OS, Ho PC (2007) A randomized comparison of side effects and patient convenience between Cyclogest1 suppositories and Endometrin1 tablets used for luteal phase support in ICSI treatment. Eur J Obstet Gynecol Reprod Biol 131:182–188PubMedCrossRefGoogle Scholar
  12. 12.
    Daya S, Gunby J (2004) Luteal phase support in assisted reproduction cycles. Cochrane Database Syst Rev CD004830Google Scholar
  13. 13.
    Nosarka S, Kruger T, Siebert I, Grove D (2005) Luteal phase support in in vitro fertilization: meta-analysis of randomized trials. Gynecol Obstet Invest 60:67–74PubMedCrossRefGoogle Scholar
  14. 14.
    Soliman S, Daya S, Collins J, Hughes EG (1994) The role of luteal phase support in infertility treatment: a meta-analysis of randomized trials. Fertil Steril 61:1068–1076PubMedGoogle Scholar
  15. 15.
    Araujo E, Bernadini L, Frederick JL, Asch RH, Balmaceda JP (1994) Prospective randomized comparison of human chorionic gonadotropin versus intramuscular progesterone for luteal phase support in assisted reproduction. J Assist Reprod Genet 11:74–78PubMedCrossRefGoogle Scholar
  16. 16.
    Levine H, Watson N (2000) Comparison of the pharmacokinetics of crinone 8 % administered vaginally versus Prometrium administered orally in postmenopausal women (3). Fertil Steril 73:516–521PubMedCrossRefGoogle Scholar
  17. 17.
    Tavaniotou A, Smitz J, Bourgain C, Devroey P (2000) Comparison between different routes of progesterone administration as luteal phase support in infertility treatments. Hum Reprod Update 6:139–148PubMedCrossRefGoogle Scholar
  18. 18.
    Penzias AS, Alper MM (2003) Luteal support with vaginal micronized progesterone gel in assisted reproduction. Reprod Biomed Online 6:287–295PubMedCrossRefGoogle Scholar
  19. 19.
    Schoolcraft WB, Hesla JS, Gee MJ (2000) Experience with progesterone gel for luteal support in a highly successful ICSI programme. Hum Reprod 15:1284–1288PubMedCrossRefGoogle Scholar
  20. 20.
    Chakmakjian ZH, Zachariah NY (1987) Bioavailability of progesterone with different modes of administration. J Reprod Med 32:443–448PubMedGoogle Scholar
  21. 21.
    Ioannidis G, Sacks G, Reddy N, Seyani L, Margara R, Lavery S, Trew G (2005) Day 14 maternal serum progesterone levels predict pregnancy outcome in ICSI/ICSI treatment cycles: a prospective study. Hum Reprod 20:741–746PubMedCrossRefGoogle Scholar
  22. 22.
    Posaci C, Smitz J, Camus M, Osmanagaoglu K, Devroey P (2000) Progesterone for the luteal support of assisted reproductive technologies: clinical options. Hum Reprod 15(Suppl 1):129–148PubMedCrossRefGoogle Scholar
  23. 23.
    Moyer DL, de Lignieres B, Driguez P, Pez JP (1993) Prevention of endometrial hyperplasia by progesterone during long-term estradiol replacement: influence of bleeding pattern and secretory changes. Fertil Steril 59:992–997PubMedGoogle Scholar
  24. 24.
    Ganesh A, Chakravorty N, Mukherjee R, Goswami S, Chaudhury K, Chakravarty B (2011) Comparison of oral dydrogesterone with progesterone gel and micronized progesterone for luteal support in 1,373 women undergoing in vitro fertilization: a randomized clinical study. Fertil Steril 95:1961–1965PubMedCrossRefGoogle Scholar
  25. 25.
    Kimzey LM, Gumowski J, Merriam GR, Grimes GJ Jr, Nelson LM (1991) Absorption of micronized progesterone from a non-liquefying vaginal cream. Fertil Steril 56:995–996PubMedGoogle Scholar
  26. 26.
    Archer D, Fahy G, Viniegra-Sibal A, Anderson FD, Snipes W, Foldesy RG (1995) Initial and steady-state pharmacokinetics of a vaginally administered formulation of progesterone. Am J Obstet Gynecol 173:471–478PubMedCrossRefGoogle Scholar
  27. 27.
    Pouly JL, Bassil S, Frydman R et al (1996) Luteal support after in vitro fertilization: crinone 8 %, a sustained release vaginal progesterone gel, vs. utrogestan, an oral micronized progesterone. Hum Reprod 11:2085–2089PubMedCrossRefGoogle Scholar
  28. 28.
    Ng EHY, Miao B, Cheung W, Ho PC (2003) A randomized comparison of side effects and patient convenience of two vaginal progesterone formulations used for luteal support in in vitro fertilization cycles. Eur J Obstet Gynecol Reprod Biol 111:50–54PubMedCrossRefGoogle Scholar

Copyright information

© Springer-Verlag 2012

Authors and Affiliations

  • Malek-Mansour Aghsa
    • 1
  • Haleh Rahmanpour
    • 2
  • Maryam Bagheri
    • 1
  • Fatemeh Davari-Tanha
    • 3
  • Reza Nasr
    • 4
  1. 1.Department of Obstetrics and Gynecology, Valie-Asr Reproductive Health Research CenterValie-Asr Hospital (TUMS)TehranIran
  2. 2.Department of Obstetrics and GynecologyAyatollah Mousavi Hospital (ZUMS)ZanjanIran
  3. 3.Department of Obstetrics and GynecologyMirza Koochak Khan Hospital (TUMS)TehranIran
  4. 4.Department of Obstetrics and GynecologyBarnet HospitalEssexUK

Personalised recommendations