A randomized trial comparing the endometrial effects of daily subcutaneous administration of 25 mg and 50 mg progesterone in aqueous preparation

Capsule:
In mock donor-egg assisted reproduction technology cycles, daily subcutaneous administration of 25 mg or 50 mg progesterone reproduces the physiologic secretory transformation of the endometrium seen in the luteal phase.

Authors:
Dominique de Ziegler, M.D., Michael Sator, M.D., Daniella Binelli, M.Sc., Chiara Leuratti Ph.D., Barbara Cometti, Ph.D., Claire Bourgain, M.D., Yao-shi X Fu, M.D., Gerhard Garhöfer, M.D.

Volume 100, Issue 3, Pages 860-866, September 2013

Abstract:

Objective:
To study the efficacy of a new P preparation in aqueous solution for subcutaneous injection for inducing the predecidual transformation of the endometrium.

Design:
Prospective, single-blinded, randomized, parallel pilot trial.

Setting:
University-affiliated clinical research center.

Patient(s):
Twenty-five regularly cycling female volunteers.

Intervention(s):
Volunteers, aged 18–45 years, body mass index 19–25 kg/m2, whose ovaries were suppressed with a GnRH agonist were estrogenized for 14 or 21 days with the use of transdermal systems delivering 0.1 mg/d E2. After confirming that the endometrial thickness was >7 mm, the women were randomized to 25 mg or 50 mg of subcutaneous P injections daily for 11 days, after which the endometrium was sampled with the use of a Pipelle device. The endometrial biopsies were evaluated by two independent pathologists. Adverse events and subjective tolerance were checked every day by the study investigator.

Main Outcome Measure(s):
Predecidual changes in endometrial biopsies obtained after 11 days of subcutaneous administration of P.

Result(s):
Of 24 biopsies performed (one dropout), 22 provided tissue for histologic analysis. Evidence of predecidual changes in the endometrial stroma was found in 100% of the cases, with no differences between the two studied doses.

Conclusion(s):
Both doses of the new aqueous P preparation available for subcutaneous administration demonstrated predecidual changes in 100% of the interpretable endometrial biopsies in total absence of endogenous P. This offers good prospect of efficacy in luteal phase support for the lowest dose tested, 25 mg/d, the physiologic amount produced daily by the ovary during the midluteal phase.

Clinical Trial Registration Number:
NCT00377923.

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