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

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/m(2), 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.

journal_name

Fertil Steril

journal_title

Fertility and sterility

authors

de Ziegler D,Sator M,Binelli D,Leuratti C,Cometti B,Bourgain C,Fu YS,Garhöfer G

doi

10.1016/j.fertnstert.2013.05.029

subject

Has Abstract

pub_date

2013-09-01 00:00:00

pages

860-6

issue

eissn

0015-0282

issn

1556-5653

pii

S0015-0282(13)00639-0

journal_volume

100

pub_type

杂志文章,随机对照试验

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