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LUTIGEST® VS. VAGINAL PROGESTERONE GEL2

Find out how the two compared in this prospective study to assess efficacy and safety for luteal support

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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 hyperstimulation2

 

METHODS

Trial type: prospective, multicentre, randomised, open-label (assessor blind) phase III study

Participants: 1,211 ART patients

Main outcome measures: biochemical, clinical, and ongoing pregnancy and live birth rates

Comparator agents for luteal phase support: Endometrin® (100 mg vaginal progesterone tablets; marketed as Lutigest® in the UK) twice daily (n = 404), 100mg three times daily (n=404) and P(4) 90 mg 8% get daily (n=403)

Protocol: progesterone for luteal phase support was administered the day after oocyte retrieval and continued for up to 10 weeks of pregnancy.

 

RESULTS

Ongoing pregnancy rate: Pregnancy rates were high and similar in all treatment groups, with biochemical rates ~50%, clinical and ongoing rate ≥40%.

Live birth rate: 35%-38% in all treatment groups

Adverse event profiles: similar across groups

 

CONCLUSION

Pregnancy rates and live birth rates for Endometrin (twice daily and three times daily) were high and similar to those for P(4) gel. The adverse event profiles for both endometrin doses were similar to that for P(4) gel and primarily due to IVF stimulation and oocyte retrieval. Endometrin was well tolerated.

 

ACCESS THE PUBMED ABSTRACT

Lutigest® resources for healthcare professionals

Including: how to use Lutigest®, clinical and real world evidence, formulations and guidelines

 SEE YOUR RESOURCES
  1. Lutigest Summary of Product Characteristics. Lutigest 100 mg vaginal tablets Available: https://www.medicines.org.uk/emc/product/3635/smpc#gref (last accessed on 01-September-2023).
  2. Doody, K.J et al. Fertility and Sterility 2009;91(4):1012-1017.

Job Code: UK-LUG-2300004 - Date of preparation: September 2023

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