Adverse Event reporting information can be found in footer

Request a Meeting





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)

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



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

Live birth rate35%-38% in all treatment groups

Adverse event profiles: similar across groups



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.



  1. Lutigest Summary of Product Characteristics. Lutigest 100 mg vaginal tablets Available: (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


Our use of cookies

We use cookies (including third party cookies) to collect data while you use this website in order to make it work, keep it secure and comply with regulations. We’d also like your consent to use cookies so we can provide you with tailored content and advertising and analyse how you and other people use the website.

Select “On” to consent to our use of these cookies and continue to the website, or select “Off” to control which types of cookies we use. You can read more about cookies in our Privacy Policy.

Necessary cookies

Necessary cookies enable core functionality such as security, network management, and accessibility. You may disable these by changing your browser settings, but this may affect how the website functions.

Analytics cookies

We’d like to set Google Analytics cookies to help us to improve our website by collecting and reporting information on how you use it. The cookies collect information in away that does not directly identify anyone. For more information on how these cookies work, please see our Privacy Policy.