Jordan, J., Craig, K., Clifton, D. K., & Soules, M. R. (1994). Luteal phase defect: the sensitivity and specificity of diagnostic methods in common clinical use. Fertility and Sterility, 62(1), 54-62. https://doi.org/10.1016/s0015-0282(16)56815-0
Jordan J, Craig K, Clifton DK, Soules MR. Luteal phase defect: the sensitivity and specificity of diagnostic methods in common clinical use. Fertil Steril. 1994;62(1):54-62. doi:10.1016/s0015-0282(16)56815-0
Jordan, John, et al. "Luteal phase defect: the sensitivity and specificity of diagnostic methods in common clinical use." Fertility and Sterility, vol. 62, no. 1, 1994, pp. 54-62.
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Department of Obstetrics and Gynecology, University of Washington, Seattle.
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RRM Academy Synopsis
Blood progesterone tests detect luteal phase defect better than charts
In a 1994 study of 34 women, a single mid-luteal blood test caught about 9 out of 10 with low progesterone output. A temperature chart caught about 1 out of 10, and ultrasound and biopsy did poorly.
About 2 in 10 women studied had low integrated progesterone, the study's standard for luteal phase defect. Source: Jordan J et al., 1994, PMID 8005304.Study at a glance, 1994 study of 34 women: A mid-luteal blood progesterone test caught luteal phase defect best. Source: Jordan J et al., 1994, PMID 8005304.
Key Findings
Of 34 women (15 normal, 19 evaluated for infertility or recurrent abortion), 7 (21%) had low integrated progesterone, the study's standard for luteal phase defect.
Basal body temperature charts, judged by three IVF doctors (reproductive endocrinologists), had 14% sensitivity and 74% specificity for luteal phase defect.
Small preovulatory follicle size on ultrasound had 14% sensitivity and 93% specificity.
Timed endometrial biopsy dated by the LH surge had 29% sensitivity and 56% specificity.
Mid-luteal blood progesterone, averaged over four random-sampling trials, had 86% sensitivity and 83% specificity for one sample. Summing three samples at the best cutoff gave 100% and 80%.
Interpretation
This study tested 34 women. Fifteen had no fertility problems. Nineteen were being treated for infertility or repeated pregnancy loss. A separate group of 58 women set the normal progesterone range. The blood test found luteal phase defect far more often than temperature charts, ultrasound, or biopsy did. The authors recommend biopsy only for cycles treated with ovulation drugs or progesterone. The authors note the group studied was small and selected. Larger studies could test how well blood progesterone predicts pregnancy outcomes.
RRM Context
Luteal phase defect is one cause to look for in infertility and repeated pregnancy loss. This fits the restorative principle that unexplained infertility is undiagnosed. The authors say blood testing depends on knowing the day of ovulation. NaProTechnology bases its hormone evaluation on charted cycle events.
Our editorial summary of this paper, not the article's abstract.
Abstract
Objective
To assess the sensitivity and specificity of common clinical tests used for the diagnosis of luteal phase defect (LPD).
Design
The sensitivity and specificity of these tests for predicting low integrated P levels over the luteal phase were calculated.
Setting
Outpatient reproductive endocrinology and infertility clinic at a university medical center.
Patients
Fifty-eight strictly defined normal women were used to determine normal integrated luteal phase P levels. The study population was a separate 34 women who either were normal (n = 15) or were being evaluated for infertility or recurrent abortion (n = 19). These 34 study subjects all had the following tests performed in the same menstrual cycle: daily reproductive hormone levels, daily assessment of preovulatory follicle size, late luteal endometrial biopsies, and BBT charts.
Main Outcome Measures
Basal body temperature, maximum preovulatory follicle size, dated endometrial biopsies, and serum P levels (single and multiple) were used in an attempt to predict which patients had low integrated P levels.
Results
Unacceptably low sensitivity and/or specificity levels were found for the following tests: appearance of BBT charts, luteal phase length, and preovulatory follicle diameter. Timed endometrial biopsy was found to have marginally acceptable sensitivity and specificity levels whether dated by next menstrual period or midcycle events. The best test for the prediction of low integrated P was a single serum P level from the midluteal phase that was < 10 ng/mL (31.8 nmol/L) or a sum of three random serum P measurements that was < 30 ng/mL (95.4 nmol/L) (also obtained in the midluteal phase).
Conclusions
Luteal phase defect is a relatively uncommon but important cause of infertility and/or habitual abortion. The recommended test for the determination of LPD is a midluteal phase single serum P level < 10 ng/mL or the sum of three serum P levels that is < 30 ng/mL. The endometrial biopsy is a second line test that is only recommended when LPD needs to be evaluated in a treated cycle (ovulation induction or supplemental P).
