SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT00703508

Developed by Shray Alag, 2019.
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

Metformin


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

Single Group Assignment


There is one SNP

SNPs


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


HPO:
Polycystic ovaries
Genes 55
SOX3 SOX9 MSX1 STK11 HNF1A LIMK1 SETD2 KLLN LIPE GTF2I ANTXR2 DHH LMNA ALMS1 CLIP2 PIK3CA CYP11B1 FOS CYP17A1 ESR1 CYP19A1 CIDEC AGPAT2 INSR FSHR NR0B1 WT1 PRKAR1A BAZ1B POR AKT1 AKT2 SRY CAVIN1 BSCL2 NR5A1 HSD3B2 ELN ATM CAV1 GNAS PPARG RFC2 PTEN GTF2IRD1 DMRT1 PLIN1 TBL2 SEC23B MAP3K1 SDHB SDHC CYB5A SDHD CBX2