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Report for Clinical Trial NCT00703508

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Pharmacogenetics of Metformin Action in PCOS

1. The polycystic ovary syndrome is the major cause of infertility in the United States. Metformin has been shown to increase frequency of ovulations in PCOS, and is used in clinical practice to treat infertility, but some women with PCOS do not respond to metformin treatment. 2. Knowing that a specific gene predicts the effect of metformin on ovulation would facilitate more efficient and effective treatment of infertility in PCOS.

NCT00703508 Polycystic Ovary Syndrome
MeSH:Polycystic Ovary Syndrome
HPO:Polycystic ovaries

1 Interventions

Name: Metformin 500 mg tablet

Description: Metformin 500 mg tablets; two tablets every 12 hours for 9 months
Type: Drug
Group Labels: 1


Primary Outcomes

Description: Responders were defined as those that had a doubling of baseline ovulation rate estimated by self-report of menstrual history.

Measure: Number of Responders/Non-responders for Each STK11 rs8111699 Genotype (C/G, C/C, G/G)

Time: 9 months

Description: Ovulations were determined by measurement of daily urine pregnanediol-3-glucuronide or weekly progesterone levels over 6-9 months of study duration for each participant. The ovulation rate was calculated as the number of confirmed ovulation events per months of study participation.

Measure: Ovulation Rate Over Study Duration for STK11 Genotypes CC, CG and GG

Time: 9 months

Secondary Outcomes

Description: Bivariate fit (RSquare with P values) of ovulation rate post treatment by change in total testosterone and Matsuda Index for each of the 3 genotypes (G/G, C/G, C/C)

Measure: Determine in Which Genotype(s) Frequency of Ovulation Correlates With Improvement in Reduction in Total Testosterone and Insulin Sensitivity as Measured by the Matsuda Index.

Time: 9 months

Purpose: Treatment

Allocation: N/A

Single Group Assignment

There is one SNP


1 rs8111699

Number of Responders/Non-responders for Each STK11 rs8111699 Genotype (C/G, C/C, G/G).

We hypothesize that women with the polycystic ovary syndrome (PCOS) who have the G/G genotype of single nucleotide polymorphism (SNP)_ rs8111699 in STK11 will exhibit a significantly greater response to metformin, in terms of ovulation, compared with women with either the C/G or C/C genotype.

HPO Nodes