Dataset for: Progesterone administration does not acutely alter LH pulse secretion in the mid-follicular phase in women

It remains unclear how rapidly progesterone suppresses luteinizing hormone (LH) pulse frequency in women. Previous studies suggested that progesterone markedly increases LH pulse amplitude but does not slow LH pulse frequency within 10 hours in estradiol-pretreated women studied during the late follicular phase. However, this experimental paradigm may be a model of preovulatory physiology, and progesterone may have different effects at other times of the cycle. We studied regularly cycling, non-obese women without hyperandrogenism to assess the acute effect of progesterone during the mid-follicular phase and in the absence of estradiol pretreatment. The study involved two admissions in separate cycles (cycle days 5-9). For each admission, either oral micronized progesterone (100 mg) or placebo was administered at 0900 h in a randomized, double-blind fashion. Frequent blood sampling was performed between 0900 and 1900 h to define 10-hour LH pulsatility. Treatment crossover (placebo exchanged for progesterone and vice versa) occurred in a subsequent cycle. After an interim futility analysis, the study was halted after 7 women completed study. Mean progesterone concentrations after placebo and progesterone administration were 0.5 ± 0.1 (mean ± SD) and 6.7 ± 1.6 ng/ml, respectively. Compared to placebo, progesterone was not associated with a significant difference in 10-hour LH pulse frequency (0.79 ± 0.35 vs. 0.77 ± 0.28 pulses/hour, p = 1.0) or amplitude (3.6 ± 2.8 vs. 4.3 ± 2.8 IU/L, p = 0.30). This study suggests that LH pulse frequency is not rapidly influenced by progesterone administration during the mid-follicular phase.

目前尚不清楚孕酮（progesterone）对女性体内黄体生成素（luteinizing hormone, LH）脉冲频率的抑制速率。既往研究表明，在卵泡晚期对经雌二醇（estradiol）预处理的女性开展研究时，孕酮可显著升高LH脉冲幅度，但在10小时内并未减缓LH脉冲频率。然而，该实验范式可能属于排卵前生理模型，孕酮在月经周期的其他时段或许会产生不同的效应。本研究纳入月经规律、非肥胖且无高雄激素血症的女性，旨在评估卵泡中期在未进行雌二醇预处理的情况下，孕酮的急性效应。本研究在两个不同的月经周期（月经第5~9天）各开展一次入院研究。每次入院时，受试者均以随机双盲的方式于每日09:00口服微粒化孕酮（micronized progesterone，100mg）或安慰剂（placebo）。于09:00至19:00期间进行频繁采血，以明确10小时内的LH搏动模式。后续周期将实施交叉治疗（即安慰剂组更换为孕酮组，孕酮组更换为安慰剂组）。在完成中期无效性分析后，本研究在7名女性完成全部研究流程后提前终止。安慰剂组与孕酮给药组的平均孕酮浓度分别为0.5±0.1（均值±标准差）与6.7±1.6 ng/ml。与安慰剂组相比，孕酮给药并未使10小时内的LH脉冲频率（0.79±0.35 vs. 0.77±0.28 次/小时，p=1.0）或脉冲幅度（3.6±2.8 vs.4.3±2.8 IU/L，p=0.30）出现显著差异。本研究结果表明，在卵泡中期，孕酮给药并不会快速影响LH脉冲频率。